Irritable Bowel Syndrome Severity Research Articles

Effectiveness of a Balanced Nine-Strain Synbiotic in Primary-Care Irritable Bowel Syndrome Patients—A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Trial

The aim of the study was to characterize effects of a multi-strain synbiotic in patients with moderate to severe irritable bowel syndrome (IBS) of all stool form types. A total of 202 adult IBS patients were randomized (1:1) and after a four-week treatment-free run-in phase and were treated either with the synbiotic or a placebo for 12 weeks. The primary endpoints were the assessment of the severity of IBS symptoms (IBS-SSS) and the improvement of IBS global symptoms (IBS-GIS). Secondary endpoints comprised adequate relief (IBS-AR scale), stool form type (Bristol Stool Form Scale), bowel movements, severity of abdominal pain and bloating, stool pressure, feeling of incomplete stool evacuation, and adverse events. A total of 201 patients completed the study. Synbiotic treatment, in comparison to placebo, significantly improved IBS-SSS and IBS-GIS scores. At the end of the treatment, 70% of patients in the synbiotic group achieved adequate relief. After 12 weeks of treatment, the secondary endpoints were favorably differentiated in the synbiotic group when compared with the placebo group. Two patients in the synbiotic group reported transient adverse events (headache). The results indicate that treatment of IBS patients with the synbiotic significantly improved all major symptoms of IBS and was well-tolerated. The ClinicalTrials.gov registration was NCT05731232.

Nutritional safety and status following a 12-week strict low FODMAP diet in patients with irritable bowel syndrome.

A low FODMAP diet (LFD) is an established dietary treatment for patients with irritable bowel syndrome (IBS). However, knowledge on the extended effects of the restriction phase regarding nutrient intake, symptom severity, and quality of life (QoL) is sparse. Therefore, our objectives were to evaluate the safety of a dietitian-led 12-week strict LFD on measures of blood biochemistry, nutritional status, symptom severity, and QoL. In this open-label dietitian-led 12-week strict LFD intervention for IBS patients with predominantly diarrhea or mixed stool pattern (IBS-D/-M), we collected data on diet intake (3-day dietary record), overnight fasting routine blood samples, body weight, IBS symptoms (IBS Severity Scoring System (IBS-SSS)), and IBS-related QoL (IBS-QoL) at baseline and after 12 weeks. Thirty-six participants completed the 12-week follow-up (mean age: 37 years, 67% women, IBS-SSS: 242 (101)). All blood parameters measured were within established reference values at both time points. We found no change in intake of macro- or micronutrients, but several micronutrients were below the recommendations both before and after 12 weeks. BMI slightly decreased, primarily driven by participants with BMI >25 (p < 0.005). QoL improved among most subdomains (p ≤ 0.002), except food avoidance and social reaction. An extended dietitian-guided LFD (12 weeks) is not inferior to the participants' baseline diet, since no clinically meaningful changes in nutritionally related blood samples and no changes in macro- or micronutrient intake were observed. However, the intake of several nutrients was below the recommendations at both time points indicating low diet quality.

A randomized, double-blinded, placebo-controlled clinical trial on Lactobacillus-containing cultured milk drink as adjuvant therapy for depression in irritable bowel syndrome

Irritable bowel syndrome (IBS) is frequently linked with coexisting mental illnesses. Our previous study discovered that 32.1% of IBS patients had subthreshold depression (SD), placing them at higher risk of developing major depression. Gut microbiota modulation through psychobiotics was found to influence depression via the gut-brain axis. However, the efficacy of lessening depression among IBS patients remains ambiguous. The study’s aim was to investigate the roles of cultured milk drinks containing 109 cfu Lactobacillus acidophilus LA-5 and Lactobacillus paracasei L. CASEI-01 on depression and related variables among IBS participants with SD. A total of 110 IBS participants with normal mood (NM) and SD, were randomly assigned to one of four intervention groups: IBS-NM with placebo, IBS-NM with probiotic, IBS-SD with placebo, and IBS-SD with probiotic. Each participant was required to consume two bottles of cultured milk every day for a duration of 12 weeks. The following outcomes were assessed: depression risk, quality of life, the severity of IBS, and hormonal changes. The depression scores were significantly reduced in IBS-SD with probiotic and placebo from baseline (p < 0.001). Only IBS-SD with probiotic showed a significant rise in serotonin serum levels (p < 0.05). A significantly higher life quality measures were seen in IBS-SD with probiotic, IBS-SD with placebo, and IBS-NM with placebo (p < 0.05). All groups, both placebo and probiotic, reported significant improvement in IBS severity post-intervention with a higher prevalence of remission and mild IBS (p < 0.05). Dual strains lactobacillus-containing cultured milk drink via its regulation of relevant biomarkers, is a potential anti-depressive prophylactic agent for IBS patients at risk.

A low FODMAP diet plus traditional dietary advice versus a low-carbohydrate diet versus pharmacological treatment in irritable bowel syndrome (CARIBS): a single-centre, single-blind, randomised controlled trial

Dietary advice and medical treatments are recommended to patients with irritable bowel syndrome (IBS). Studies have not yet compared the efficacy of dietary treatment with pharmacological treatment targeting the predominant IBS symptom. We therefore aimed to compare the effects of two restrictive dietary treatment options versus optimised medical treatment in people with IBS. This single-centre, single-blind, randomised controlled trial was conducted in a specialised outpatient clinic at the Sahlgrenska University Hospital, Gothenburg, Sweden. Participants (aged ≥18 years) with moderate-to-severe IBS (Rome IV; IBS Severity Scoring System [IBS-SSS] ≥175) and no other serious diseases or food allergies were randomly assigned (1:1:1) by web-based randomisation to receive a diet low in fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAPs) plus traditional IBS dietary advice recommended by the UK National Institute for Health and Care Excellence (hereafter the LFTD diet), a fibre-optimised diet low in total carbohydrates and high in protein and fat (hereafter the low-carbohydrate diet), or optimised medical treatment based on predominant IBS symptom. Participants were masked to the names of the diets, but the pharmacological treatment was open-label. The intervention lasted 4 weeks, after which time participants in the dietary interventions were unmasked to their diets and encouraged to continue during 6 months' follow-up, participants in the LFTD group were instructed on how to reintroduce FODMAPs, and participants receiving pharmacological treatment were offered diet counselling and to continue with their medication. The primary endpoint was the proportion of participants who responded to the 4-week intervention, defined as a reduction of 50 or more in IBS-SSS relative to baseline, and was analysed per modified intention-to-treat (ie, all participants who started the intervention). Safety was analysed in the modified intention-to-treat population. This trial is registered with ClinicalTrials.gov, NCT02970591, and is complete. Between Jan 24, 2017, and Sept 2, 2021, 1104 participants were assessed for eligibility and 304 were randomly assigned. Ten participants did not receive their intervention after randomisation and thus 294 participants were included in the modified intention-to-treat population (96 assigned to the LFTD diet, 97 to the low-carbohydrate diet, and 101 to optimised medical treatment). 241 (82%) of 294 participants were women and 53 (18%) were men and the mean age was 38 (SD 13). After 4 weeks, 73 (76%) of 96 participants in the LFTD diet group, 69 (71%) of 97 participants in the low-carbohydrate diet group, and 59 (58%) of 101 participants in the optimised medical treatment group had a reduction of 50 or more in IBS-SSS compared with baseline, with a significant difference between the groups (p=0·023). 91 (95%) of 96 participants completed 4 weeks in the LFTD group, 92 (95%) of 97 completed 4 weeks in the low-carbohydrate group, and 91 (90%) of 101 completed 4 weeks in the optimised medical treatment group. Two individuals in each of the intervention groups stated that adverse events were the reason for discontinuing the 4-week intervention. Five (5%) of 91 participants in the optimised medical treatment group stopped treatment prematurely due to side-effects. No serious adverse events or treatment-related deaths occurred. Two 4-week dietary interventions and optimised medical treatment reduced the severity of IBS symptoms, with a larger effect size in the diet groups. Dietary interventions might be considered as an initial treatment for patients with IBS. Research is needed to enable personalised treatment strategies. The Healthcare Board Region Västra Götaland, the Swedish Research Council, the Swedish Research Council for Health, Working Life and Welfare, AFA Insurance, grants from the Swedish state, the Wilhelm and Martina Lundgren Science Foundation, Skandia, the Dietary Science Foundation, and the Nanna Swartz Foundation.

The role of cognitive emotion regulation strategies in predicting the resilience, symptom severity, and quality of life of patients with irritable bowel syndrome

BackgroundPsychosocial stressors contribute to the development of irritable bowel syndrome (IBS) and exacerbate the symptoms. The capability to cope with stress is an essential element in the management of IBS. This study assessed nine cognitive emotion regulation strategies (CERS) and their role in predicting symptom severity, quality of life (QOL), and resilience in IBS subjects. MethodsThe scores regarding nine subscales of CERS were obtained by cognitive emotion regulation questionnaire (CERQ) and compared between study patients based on the severity and subtypes of IBS using one-way ANOVA. To evaluate the predictive role of CERS, logistic regression was performed. The correlation between CERS and the QOL was assessed by Pearson correlation analysis. The score of resilience was measured by Connor-Davidson Resilience Scale (CD-RISC). ResultsWe recruited 100 patients diagnosed with IBS based on ROME IV criteria. Among nine subscales of CERS, patients with more severe symptoms scored higher in catastrophizing (p < 0.001) and blaming others (p = 0.015) while lower in positive reappraisal (p = 0.028). Blaming others was the only predictor of resilience and severity of IBS in our patients (odds ratio (OR): -2.103, p=0.028, and OR:1.715, p = 0.049, respectively). We observed significant negative correlations between the quality of life and rumination (r= -0.202, p=0.044), self-blame (r= -0.241, p=0.016), catastrophizing (r= -0.342, p<0.001), and blaming others (r= -0.219, p=0.028). ConclusionMaladaptive strategies are more common in IBS patients with more severe symptoms and have negative correlations with the QOL. Blaming others has the potential to predict the resilience and severity of symptoms in IBS patients.

THE MOST COMMON DISORDERS OF THE INTESTINE-BRAIN AXIS IN PATIENTS WITH GLUTEN-DEPENDENT DISEASES ON THE BACKGROUND OF MEDICAL NUTRITION AND THE POSSIBILITY OF THEIR CORRECTION

Background. At least 20% of people with celiac disease (CD) continue to experience symptoms during a gluten-free diet (GFD). Other estimates indicate that more than one-third of individuals with celiac disease have symptoms similar to those seen in disorders of gut-brain interaction (particularly irritable bowel syndrome (IBS) or functional dyspepsia). Similarly, approximately 25% of individuals with non-celiac gluten sensitivity (NCGS) continue to have unexplained complaints during a GFD.&#x0D; Aim: To investigate and evaluate the potential correction of IBS-like symptoms in patients with celiac disease and NCGS adhering to a GFD using a probiotic.&#x0D; Materials and Methods. The study included 42 adult participants, of whom 22 (52.38%) had celiac disease, and 20 (47.62%) had NCGS. Patient surveys, using the Irritable Bowel Syndrome Severity Scoring System (IBS-SSS), were conducted in April-May 2023 before and after the administration of a multi-strain probiotic containing Lactobacillus plantarum CECT7484, Lactobacillus plantarum CECT7485, Pediococcus acidilactici CECT7483 - at least 3x10⁹ CFU. The duration of the probiotic treatment was 30 days. The data obtained were processed using the "Statistica 10.0" software package.&#x0D; Results. After a 30-day course of probiotic intake, a significant reduction in the severity of IBS-like symptoms (p=0.00005) was observed in the majority of patients with gluten-sensitive pathology according to the IBS-SSS questionnaire: symptom reduction was noted in 29 patients (69%), no change in condition in 7 patients (17%), worsening of the condition and increased severity of complaints in 6 patients (14%). The severity of IBS-like symptoms determined the treatment response: in patients with IBS and more pronounced symptoms, the probiotic showed significantly greater effectiveness, particularly in cases with pronounced complaints (bloating, constipation, diarrhea, abdominal pain) (p=0.009376) and in moderate cases (p=0.000379). The probiotic most effectively influenced bloating in both patient groups (p=0.003699).&#x0D; Conclusion. The combination of two strains of Lactobacillus plantarum (CECT7484 and CECT7485) and one strain of Pediococcus acidilactici (CECT7483) can be effectively used to correct IBS-like complaints in patients with celiac disease and NCGS who have complaints despite adhering to a GFD.

Utility of irritable bowel syndrome subtypes and most troublesome symptom in predicting disease impact and burden.

Little is known about the characteristics of individuals with irritable bowel syndrome (IBS) according to stool subtype or the most troublesome symptom reported by the individual, or whether these are useful in predicting the impact of IBS. We collected demographic, gastrointestinal, and psychological symptoms, healthcare usage and direct healthcare costs, impact on work and activities of daily living, and quality of life data from individuals with Rome IV-defined IBS. We recruited 752 people with Rome IV IBS. Individuals with IBS-D reported a poorer disease-specific quality of life than those with IBS-C or IBS-M (mean (SD) IBS-QOL 45.3 (23.0) for IBS-D, vs. 52.3 (19.9) for IBS-C, vs. 49.4 (22.0) for IBS-M, p = 0.005). Mean (SD) IBS-QOL scores were also lower amongst those who reported diarrhea (44.8 (22.3)) or urgency (44.6 (22.3)) as their most troublesome symptom, compared with those reporting abdominal pain (52.2 (22.9)), constipation (49.5 (21.8)), or abdominal bloating or distension (50.4 (21.3)). However, there were no differences in mean EQ-5D scores, IBS severity, levels of anxiety, depression, somatoform symptom-reporting, or gastrointestinal symptom-specific anxiety. Direct healthcare costs of IBS were similar across all subtypes and all most troublesome symptom groups, although some differences in work productivity and social leisure activities were detected. There appears to be limited variation in the characteristics of individuals with Rome IV IBS based on both stool subtypes and most troublesome symptom reported, suggesting that gastrointestinal symptoms alone have limited ability to predict disease impact and burden.

Anxiety-Related Factors Associated With Symptom Severity in Irritable Bowel Syndrome in Jazan, Saudi Arabia.

This study in Jazan, Saudi Arabia aims to identify anxiety-related factors associated with symptom severity in irritable bowel syndrome (IBS). IBS is a common gastrointestinal disorder causing abdominal pain and altered bowel habits. The prevalence of IBS in Saudi Arabia is estimated to be 10%-20% among the general population. Therefore, the present study aimed todetermine anxiety-related factors associated with symptom severity in irritable bowel syndrome in Jazan, Saudi Arabia. Understanding these factors will provide insights into the overall impact of IBS on patients' quality of life. The study utilized a cross-sectional, descriptive observational design to examine the general population in Jazan, Saudi Arabia. The sample size of 385 individuals was calculated based on the population size and desired error margin. A convenience sampling technique was employed to select participants who met the inclusion criteria. A validated anonymous self-administered electronic survey was distributed through social media channels. The survey consisted of four sections gathering demographic information, personal risk factors, IBS types with anxiety and risk factors, and a questionnaire to determine the level of anxiety. A pilot study was conducted to improve the survey's clarity. Ethical considerations were followed, and data were analyzed using Statistical Package for Social Sciences (SPSS; IBM Corp., Armonk, NY, USA). Descriptive statistics and significance tests were performed. A study with 637 participants found a 31.08% prevalence of IBS, which was more common in females. Participants with IBS had a higher rate of chronic disease. There were no significant differences in demographic factors between IBS and non-IBS participants. The duration of IBS diagnosis varied, with the majority of IBS with diarrhea (IBS-D) sufferers being diagnosed five years prior. Symptom severity differed among IBS types, with those with an unspecified type reporting the highest percentage of severe symptoms. IBS types were also correlated with anxiety levels, with IBS-D sufferers reporting moderate anxiety and those with an unspecified type reporting severe anxiety. A study with 637 participants found the prevalence of IBS to be 31.08%, with higher rates in females. IBS was associated with chronic diseases and higher anxiety levels. The findings emphasize the need for comprehensive management of IBS, including psychological interventions and dietary modifications, to improve patients' overall health and quality of life. Further research on genetic and modifiable risk factors is needed.

A follow-up study of anxiety and depressive symptoms in irritable bowel syndrome.

Irritable bowel syndrome (IBS) is a functional gastrointestinal (GI) disorder and is closely linked to stress. Psychiatric morbidities such as anxiety and depression are common in IBS. Long-term follow-up studies on anxiety and depressive symptoms in IBS and the impact of treatment are lacking in the Indian scenario. This study aimed to assess the various subtypes of IBS according to the Rome IV criteria, assess anxiety and depressive symptoms in patients with IBS at baseline and also at various phases of follow-up over one year, and see the impact of the treatment of both IBS and associated anxiety and depressive symptoms if present, in the severity of IBS and other psychiatric symptoms. Patients with IBS, aged between 18 and 65 years, were enrolled for the study. Subtypes and severity of IBS were assessed. Anxiety and depressive symptoms were assessed by the Hamilton Rating Scale for Anxiety (HAM-A) and the Hamilton Rating Scale for Depression (HAM-D), respectively. The patients were treated with conventional treatment of IBS with concomitant treatment of anxiety and depressive symptoms and were followed up for 1 year. Thirty-seven patients completed a 1-year follow-up. The mean age was 38.4 ± 11.6 years. The majority were males (81%), and IBS-D (84%) was the most common subtype. Stressful life events (67.6%) and chronic stressors (64.9%) were present in the majority of the patients. The patients had moderate-to-severe anxiety at baseline (HAM-A score 27.8 ± 6.4) and moderate-to-severe depression at baseline (HAM-D score 19.7 ± 6.6). The improvement over 1 year was statistically significant (P = 0.000, two-tailed). A positive correlation between the severity score of IBS and HAM-D (r = 0.604) and HAM-A (r = 0.536) scores was present. There is a high prevalence of anxiety and depression in patients with IBS. With adequate treatment of both IBS and concomitant anxiety-depressive symptoms, there is a significant decrease in the severity of IBS, anxiety, and depression.

NHE3 inhibitor tenapanor maintains intestinal barrier function, decreases visceral hypersensitivity, and attenuates TRPV1 signaling in colonic sensory neurons.

The pathogenesis of irritable bowel syndrome (IBS) is multifactorial, characterized in part by increased intestinal permeability, and visceral hypersensitivity. Increased permeability is associated with IBS severity and abdominal pain. Tenapanor is FDA-approved for the treatment of IBS with constipation (IBS-C) and has demonstrated improvements in bowel motility and a reduction in IBS-related pain; however, the mechanism by which tenapanor mediates these functions remains unclear. Here, the effects of tenapanor on colonic pain signaling and intestinal permeability were assessed through behavioral, electrophysiological, and cell culture experiments. Intestinal motility studies in rats and humans demonstrated that tenapanor increased luminal sodium and water retention and gastrointestinal transit versus placebo. A significantly reduced visceral motor reflex (VMR) to colonic distension was observed with tenapanor treatment versus vehicle in two rat models of visceral hypersensitivity (neonatal acetic acid sensitization and partial restraint stress; both P < 0.05), returning VMR responses to that of nonsensitized controls. Whole cell voltage patch-clamp recordings of retrogradely labeled colonic dorsal root ganglia (DRG) neurons from sensitized rats found that tenapanor significantly reduced DRG neuron hyperexcitability to capsaicin versus vehicle (P < 0.05), an effect not mediated by epithelial cell secretions. Tenapanor also attenuated increases in intestinal permeability in human colon monolayer cultures caused by incubation with proinflammatory cytokines (P < 0.001) or fecal supernatants from patients with IBS-C (P < 0.005). These results support a model in which tenapanor reduces IBS-related pain by strengthening the intestinal barrier, thereby decreasing permeability to macromolecules and antigens and reducing DRG-mediated pain signaling.NEW & NOTEWORTHY A series of nonclinical experiments support the theory that tenapanor inhibits IBS-C-related pain by strengthening the intestinal barrier. Tenapanor treatment reduced visceral motor responses to nonsensitized levels in two rat models of hypersensitivity and reduced responses to capsaicin in sensitized colonic nociceptive dorsal root ganglia neurons. Intestinal permeability experiments in human colon monolayer cultures found that tenapanor attenuates increases in permeability induced by either inflammatory cytokines or fecal supernatants from patients with IBS-C.

Limosilactobacillus reuteri DSM 17938 and ATCC PTA 6475 for the treatment of moderate to severe irritable bowel syndrome in adults: a randomized controlled trial

BackgroundIrritable bowel syndrome (IBS) is a common functional gastrointestinal disorder in adults. Systematic reviews with meta-analyses have demonstrated the efficacy and safety of probiotics in improving symptoms of IBS.AimThe aim of the study was to demonstrate the efficacy and safety of Limosilactobacillus reuteri (L. reuteri) DSM 17938 combined with L. reuteri ATCC PTA 6475 regarding improving the symptoms associated with IBS in adults.MethodsA randomized, double-blind, placebo-controlled clinical trial was conducted in 140 adults aged 18 years to 65 years with a diagnosis of IBS (based on the Rome IV criteria). After 2 weeks of washout, subjects were randomized to receive either 2 × 108 colony-forming units (CFUs) of L. reuteri DSM 17938 combined with L. reuteri ATCC PTA 6475 plus standard of care or placebo plus standard of care for 14 weeks, followed by a post-intervention period of 2 additional weeks. Changes in gastrointestinal symptoms (as measured with the GSRS-IBS), stool pattern (as measured with the Bristol scale), quality of life, depression and anxiety, frequency of adverse events, and fecal calprotectin concentrations were evaluated.ResultsIn total, 70 subjects were allocated to receive L. reuteri and 70 were allocated to receive placebo. During the pre-randomization phase, no differences were observed between the groups in terms of IBS-associated symptoms and stool consistency. Starting at week 6 of the intervention, subjects in group L. reuteri showed a significant improvement in IBS-associated symptoms (p &amp;lt; 0.01). A significant improvement was also observed in fecal calprotectin concentration in the L. reuteri group at the end of interventions (30.2 ± 11.8 mg/g of stool in the L. reuteri group and 41.6 mg/g ± 10.7 mg/g in the placebo group; p = 0.019). The frequency of adverse events was similar between groups.ConclusionsA twice-a-day intervention for 14 weeks is safe and effective, reduces the symptoms associated with IBS in adults aged 18 years to 65 years, improves stool consistency, and reduces symptoms associated with anxiety after 6 weeks.

Yoga and Naturopathy intervention on psychological comorbidities and autonomic function for irritable bowel syndrome patient: A case study

Irritable bowel syndrome (IBS) is a common functional disorder of the gut-brain axis, characterized by abdominal pain and altered bowel habits. A 38-year-old male patient with a sedentary lifestyle, diagnosed with IBS based on Rome IV criteria, was underwent Yoga and Naturopathy interventions for one month in our outpatient department. The result showed a reduced Irritable Bowel Syndrome Severity Score (IBS-SSS) (315 to 109) and perceived stress (PSS) score (29 to 12) level. Heart rate variability (HRV) analysis showed increased SDNN (35.4 to 48.3 ms) and RMSSD (41.3 to 58.3 ms) values, indicative of improved HRV. Notably, parasympathetic dominance was observed, evidenced by increased pNN50% (14.56 to 18.41) and H.F (41.92 to 59.63 n.u) values, while the LF/HF ratio (1.381 to 0.675) decreased. This case report suggests that lifestyle change through Yoga and Naturopathic intervention is useful in the management of IBS with psychological co-morbidities .

Translation, validation, and first application of the Greek version of an irritable bowel syndrome severity scoring system.

The Irritable Bowel Syndrome Severity Scoring System (IBS-SSS) is a self-administered questionnaire that categorizes patients according to symptom severity. We aimed to translate and adapt the English IBS-SSS, validate the Greek version, and detect factors predictive of IBS severity. The original English version was obtained from the Rome Foundation, and the final Greek version arose through a process of translation, comprehensibility evaluation and back-translation. The 141 participants enlisted in the study were enrolled from 2 tertiary hospitals and were divided into 2 groups (98 patients and 43 healthy volunteers). We evaluated the questionnaire properties based on COSMIN criteria. The recruited patients reported either diarrhea-predominant (34.7%), constipation-predominant (28.6%), or mixed subtype (36.7%) IBS. No significant variations were found regarding the frequency and intensity of abdominal pain and flatulence among the 3 IBS subtypes. Severity scores among healthy volunteers were significantly lower compared to IBS patients, irrespective of their disease subtype (P<0.001). The Cronbach coefficient (α) was calculated at 0.953, suggesting high inter-item internal consistency. The intraclass correlation coefficient was calculated and found to be high, suggesting good responsiveness of the questionnaire. Two-way MANOVA evaluation showed that demographic variables (age, family status, body mass index [BMI], smoking, and alcohol consumption) in the Greek population affect the IBS-SSS score and syndrome severity. The Greek version of IBS-SSS is a reliable, valid and responsive tool for assessing Greek IBS patients' symptom severity. Older age, smoking, alcohol use and higher BMI are indicative of greater symptom severity.

Amitriptyline at Low-Dose and Titrated for Irritable Bowel Syndrome as Second-Line Treatment in primary care (ATLANTIS): a randomised, double-blind, placebo-controlled, phase 3 trial

Most patients with irritable bowel syndrome (IBS) are managed in primary care. When first-line therapies for IBS are ineffective, the UK National Institute for Health and Care Excellence guideline suggests considering low- dose tricyclic antidepressants as second-line treatment, but their effectiveness in primary care is unknown, and they are infrequently prescribed in this setting. This randomised, double-blind, placebo-controlled trial (Amitriptyline at Low-Dose and Titrated for Irritable Bowel Syndrome as Second-Line Treatment [ATLANTIS]) was conducted at 55 general practices in England. Eligible participants were aged 18 years or older, with Rome IV IBS of any subtype, and ongoing symptoms (IBS Severity Scoring System [IBS-SSS] score ≥75 points) despite dietary changes and first-line therapies, a normal full blood count and C-reactive protein, negative coeliac serology, and no evidence of suicidal ideation. Participants were randomly assigned (1:1) to low-dose oral amitriptyline (10 mg once daily) or placebo for 6 months, with dose titration over 3 weeks (up to 30 mg once daily), according to symptoms and tolerability. Participants, their general practitioners, investigators, and the analysis team were all masked to allocation throughout the trial. The primary outcome was the IBS-SSS score at 6 months. Effectiveness analyses were according to intention-to-treat; safety analyses were on all participants who took at least one dose of the trial medication. This trial is registered with the ISRCTN Registry (ISRCTN48075063) and is closed to new participants. Between Oct 18, 2019, and April 11, 2022, 463 participants (mean age 48·5 years [SD 16·1], 315 [68%] female to 148 [32%] male) were randomly allocated to receive low-dose amitriptyline (232) or placebo (231). Intention-to-treat analysis of the primary outcome showed a significant difference in favour of low-dose amitriptyline in IBS-SSS score between groups at 6 months (-27·0, 95% CI -46·9 to -7·10; p=0·0079). 46 (20%) participants discontinued low-dose amitriptyline (30 [13%] due to adverse events), and 59 (26%) discontinued placebo (20 [9%] due to adverse events) before 6 months. There were five serious adverse reactions (two in the amitriptyline group and three in the placebo group), and five serious adverse events unrelated to trial medication. To our knowledge, this is the largest trial of a tricyclic antidepressant in IBS ever conducted. Titrated low-dose amitriptyline was superior to placebo as a second-line treatment for IBS in primary care across multiple outcomes, and was safe and well tolerated. General practitioners should offer low-dose amitriptyline to patients with IBS whose symptoms do not improve with first-line therapies, with appropriate support to guide patient-led dose titration, such as the self-titration document developed for this trial. National Institute for Health and Care Research Health Technology Assessment Programme (grant reference 16/162/01).

Drug therapy's new options in the treatment of the severe irritable bowel syndrome

Stress, individual characteristics of each patient, visceral hypersensitivity and intestinal motility have the key importance in the pathogenesis of irritable bowel syndrome (IBS). In recent years, there has been growing interest in the use of selective serotonin and norepinephrine reuptake inhibitors (SNRIs) in the complex therapy of IBS patients with somatoform disorders. To examine the effectiveness of the SNRIs antidepressant therapy in the treatment of patients with IBS and diarrhea (IBS-D) with extraintestinal manifestations. 42 patients with severe IBS and diarrhea (IBS-D) were examined, among them 22 female with a median age of 32 years old (22; 38), and 20 male with a median age of 31 years old (25; 35). Treatment with duloxetine 60 mg/day was prescribed. The effectiveness of the therapy was assessed after eight weeks. The IBS clinical symptoms dynamics were assessed by the intensity of pain syndrome and bloating, which were determined using Visual Analogue Pain Scale (VAS), stool frequency and shape based on the Bristol stool scale; Visceral sensitivity threshold was assessed according to the Balloon dilatation test. There was studied the effect of the duloxetine on the extraintestinal manifestations of IBS. The psycho-emotional state was assessed using the Beck scale of anxiety and depression and the Spielberger-Khanin scale by psychiatrist, neurologist-vegetol. All patients showed positive dynamics after eight weeks duloxetine treatment: the decrease of pain syndrome from 9 (9; 10) to 2 (2; 3) points, bloating from 8 (8; 9) points to 2,5 (1; 3) points according to VAS, and defecation frequency from 10 (9; 12) to 2 (1; 2) times a day; the change of stool consistency from 6th (6; 7) to 3rd (3; 4) type. The visceral sensitivity threshold increased: the time of appearance of the first urge to defecate increased from 56 (34; 74) ml to 95 (80; 98) ml. Significantly decreased extraintestinal manifestations of IBS. In reassessing each patient's individual characteristics there were the decrease of the depression level according to the Beck scale from 26 (23; 32) to 11.5 (10; 13) points and personal personal anxiety level according to the Spielberger-Khanin scale from 42.5 (35; 53) to 22 (20; 24) points, as well as the decrease of situational anxiety from 40 (37; 49) to 22 (21; 36) points. The severe course of IBS-D is mainly associated with the patients' individual characteristics and anxiety or anxiety-depressive syndromes. The positive impact of duloxetine therapy in severe IBS-D with extraintestinal manifestations is associated with the regulation of serotonergic and noradrenergic activity of the central.

A starch- and sucrose-reduced diet may lead to improvement of intestinal and extraintestinal symptoms in more conditions than irritable bowel syndrome and congenital sucrase-isomaltase deficiency

ObjectivesA starch- and sucrose-reduced diet has been found to improve gastrointestinal and extraintestinal symptoms in irritable bowel syndrome, as well as reduce weight and improve psychological well-being. Our hypothesis was that a starch- and sucrose-reduced diet would also be beneficial in other conditions with similar symptoms. The aim of the present research letter was to describe the role of a starch- and sucrose-reduced diet in a pilot project in patients with diarrhea having varying causes. MethodsOne man, age 36 y, suffering from functional diarrhea and one woman, 56 y, suffering from microscopic colitis, were randomized to a starch- and sucrose-reduced diet for 4 wk. At baseline, dietary information was given, and blood samples collected. Weight and waist circumference were measured. The participants completed the irritable bowel syndrome severity scoring system for evaluating specific gastrointestinal and extraintestinal symptoms and visual analog scale for irritable bowel syndrome for evaluation of specific gastrointestinal symptoms and psychological well-being. The degrees of satiety and sweet craving were measured on visual analog scales. After 4 wk, all procedures were repeated. ResultsWeight, body mass index, and waist circumference were decreased during the intervention. The total amount of gastrointestinal symptoms was decreased in the participants with functional diarrhea, and diarrhea and bloating were decreased in both participants. Both had reduced extraintestinal symptoms and improved psychological well-being. Blood levels had mainly unchanged or slightly increased values of measurements reflecting nutrient intake. ConclusionsA starch- and sucrose-reduced diet may lead to weight reduction, reduced symptoms, and improved well-being in several patient categories, not only in patients suffering from irritable bowel syndrome. Future randomized trials should be done.

Effectiveness of Osteopathic Manipulative Treatment in Adults with Irritable Bowel Syndrome: A Systematic Review and Meta-Analysis.

The aim of this systematic review and meta-analysis was to evaluate the effectiveness of the osteopathic manipulative treatment (OMT) in adults with irritable bowel syndrome (IBS). A literature resview was carried out on the following databases: PubMed, Embase, Cochrane, Cinahl, Scopus, PEDro and ClinicalTrials.gov. 350 articles were recovered. Eligibility criteria were evaluated by two independent reviewers, including randomized controlled trials (RCTs), quasi-RCTs, or ongoing RCTs with OMT compared to any kind of control in patients diagnosed with IBS. Six studies (five RCTs and one ongoing RCT) were considered eligible. Four RCTs were classified as some concerns and one as high risk of bias. In the meta-analysis, OMT compared to sham/no intervention showed statistically significant results for abdominal pain (effect size ES = -1.14 [-1.66, -0.62]; p < 0.0001) and constipation (ES = -0.66 [-1.12, -0.20]; p = 0.005). Instead, OMT was not superior to the control for the IBS symptoms measured with the IBS Severity Score and the Likert scale (ES = -0.34 [-0.83, 0.16]; p = 0.19), and diarrhea (ES = -1.20 [-2.84, 0.43]; p = 0.15). The quality of evidence was "low" for IBS symptoms in general for abdominal pain and constipation, while it was judged as "very low" for diarrhea. OMT turns out to be safe in the treatment of IBS without major adverse effects. OMT may be effective in IBS patients, however the results must be interpreted carefully due to the low methodological quality of the studies.

Washed microbiota transplantation targeting both gastrointestinal and extraintestinal symptoms in patients with irritable bowel syndrome

ObjectiveFecal microbiota transplantation (FMT) has been reported with the treatment potential for irritable bowel syndrome (IBS). However, the knowledge of its effect on extraintestinal symptoms of IBS is limited. This study aimed to evaluate the efficacy of the improved methodology of FMT, washed microbiota transplantation (WMT), on sleep disturbances, and psychological and gastrointestinal symptoms among patients with IBS. MethodsThis was a prospective observational study involving patients with IBS who underwent WMT. The Pittsburgh Sleep Quality Index (PSQI) was used to assess sleep quality. The Gastrointestinal Symptom Rating Scale (GSRS) and IBS Severity Scoring System (IBS-SSS) were used to evaluate gastrointestinal symptoms and IBS severity, respectively. The Self-rating Depression Scale (SDS) and Self-rating Anxiety Scale (SAS) were used to evaluate depression and anxiety, respectively. All the symptoms were evaluated at baseline and one month after WMT. A multiple logistic regression model was used to determine the predictive factors of sleep improvement one month after WMT. ResultsSeventy-three patients with IBS were included in the study. Sleep quality (Z = −4.211, P < 0.001), anxiety (Z = −4.775, P < 0.001), depression (Z = −4.610, P < 0.001), gastrointestinal symptoms (Z = −5.364, P < 0.001), and IBS severity (Z = −6.468, P < 0.001) significantly improved one month after WMT in all patients. The scores of the five components of PSQI including subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, and sleep disturbances decreased in 52 patients with poor sleep quality (all P < 0.05). Baseline sleep duration scores were identified as an independent predictive factor of sleep improvement one month after WMT in patients with poor sleep quality (OR 2.180 [95% CI = 1.017–4.673]; P = 0.045). Patients that experienced sleep improvement demonstrated greater alleviation in depression (Z = −1.990, P = 0.047) and IBS severity (Z = −2.486, P = 0.013) compared with patients without sleep improvement. ConclusionThis study suggested that WMT might be a promising therapy for patients with IBS, especially those with comorbid sleep and psychological disorders.

Assessment of Sleep Quality Among Adolescents and Adults With Self-Diagnosed Irritable Bowel Syndrome, in Jeddah, Saudi Arabia.

Background The frequency of irritable bowel syndrome (IBS) has increased significantly in the last ten years. Few studies were done in Saudi Arabia to assess the relationship between sleep quality and IBS. This study aims to assess the prevalence of IBS and its association with sleep quality among adolescents and adults in Saudi Arabia. Methods A cross-sectional study was done on 651 participants aged 15-65 years. An online questionnaire was used to collect data, including demographics; the Rome IV criteria (R4DQ) was used in the diagnosis of IBS, the IBS symptoms severity scale (IBS-SSS) assessed IBS symptoms and severity, and the Pittsburgh Sleep Quality Index (PSQI) was used to assess sleep quality. Results Based on the Rome IV criteria, 25.7% of the participants had IBS. Among them, 23.3%, 17.9%, 47.3%, and 11.5% had IBS types constipation (C), diarrhea (D), mixed bowel habits (M), and undefined subtype (U), respectively. Mild, moderate, and severe IBS were found among 43.1%, 39.5%, and 17.4% of IBS cases, respectively. About 46% had poor sleep quality, which was significantly higher among those with younger mean age, females, and students. Patients with IBS exhibited a considerably greater prevalence of poor sleep quality, and IBS-C had the highest prevalence. Conclusion A correlation was found between poor sleep quality and the positive status of IBS diagnosis among adolescents and adults. An evaluation of specific sleep disorders among IBS patients is needed.

The Efficacy and Safety of Single-Strain Probiotic Formulations Containing Bifidobacterium lactis or Bacillus coagulans in Adult Patients with Irritable Bowel Syndrome-A Randomized Double-Blind Placebo-Controlled Three-Arm Interventional Trial.

Probiotics offer a potential new therapeutic approach for irritable bowel syndrome (IBS), but current results are still controversial. The aim of this study was to assess the efficacy and safety of single-strain probiotic formulations in adult IBS patients and to compare the effects of Bifidobacterium lactis NORDBIOTIC™ BI040 (DSM 33812/34614) and Bacillus coagulans NORDBIOTIC™ BC300 (DSM 33836) in a prospective three-arm interventional randomized double-blind placebo-controlled clinical trial. The study included 123 IBS subjects diagnosed according to the Rome IV criteria. The primary outcomes were changes in symptom severity and symptom improvement as assessed using the IBS Severity Scoring System (IBS-SSS) after 4, 8, and 12 weeks of intervention and after 4 weeks of follow-up. Secondary outcomes included the assessment of individual IBS symptoms and the occurrence of adverse events. During the 12-week intervention, IBS-SSS scores significantly decreased (p-values < 0.001) in the study groups but differences between the interventional and placebo groups did not reach statistical significance. However, at the 16th week of follow-up, a significant improvement in the total IBS-SSS score in comparison to the placebo group (20.5%) was found in 43.8% and 52.9% of the Bifidobacterium lactis (p = 0.038, OR 3.0, [95% CI 1.1-8.6]) and the Bacillus coagulans (p = 0.005, OR 4.6 [95% CI 1.5-12.2]) groups, respectively. Bifidobacterium lactis had a beneficial effect on the intensity and frequency of pain, whereas Bacillus coagulans decreased the bowel dissatisfaction. Both strains increased the percentage of patients with normal stool consistency, but only Bifidobacterium lactis induced a decrease in the number of patients with constipation after 6 weeks of supplementation. Both probiotic strains were well tolerated, without differences in the occurrence of adverse events between groups. In conclusion, single-strain supplementation was safe and efficient in IBS patients but showed a different range of effects. Bifidobacterium lactis BI040 primarily reduced the frequency and intensity of pain, while Bacillus coagulans BC300 increased bowel satisfaction [ClinicalTrials.gov NCT05064930].