Increased Stool Frequency Research Articles

Comparing the Safety and Efficacy of Two Different Synbiotics in the Treatment of Infantile Functional Constipation Resistant to Non-Pharmacological Therapy: A Randomized Clinical Trial

Background: Recent evidence emphasizes the positive effect of probiotics and synbiotics in the treatment of functional constipation in childhood, but no study has surveyed the effectiveness of synbiotics in improving the clinical conditions in infants ≤6 months suffering from functional constipation, so we performed this study. Aims: Comparing the efficacy and safety of two types of synbiotics including PediLact® (Zist-Takhmir Co., Tehran, Iran) drop containing Bifidobacterium infantis, Lactobacillus reuteri, Lactobacillus rhamnosus plus fructooligosaccharides with BBCare® (Zist-Takhmir Co., Tehran, Iran) drop containing Bifidobacterium lactis BB-12 plus fructooligosaccharides in the treatment of infantile functional constipation. Study Design: This trial was performed on infants less than 6 months of age who met the ROME IV criteria for infantile functional constipation. The patients were randomly assigned to receive PediLact drop (n = 44) or BB-Care drop (n = 45) for one month and were evaluated on the seventh day and at the end of the first month. Results: A significant downward trend was revealed in the responsive rate of every clinical symptom in both intervention groups but BB-Care was more effective than PediLact in improving the frequency of weekly defecation. Both synbiotics also improved significantly all symptoms of constipation in all types of feeding methods after one week and one month of intervention (primary outcomes). There was no side effect of synbiotics through intervention (secondary outcome). Conclusions: This study shows that both synbiotics improved significantly all symptoms of functional constipation after one week and one month of intervention apart from type of feeding method in infants less than 6 months of age. Due to the greater effectiveness of BB-care in increasing stool frequency, B. lactis may play a more prominent role in this age group. This study has been registered at the Iranian Registry of Clinical Trails (IRCT20160827029535N7).

Functional Outcome in Children with Hirschsprung’s Disease after Modified Duhamel’s Procedure: A Longitudinal Study

Introduction: The classical surgical treatment of Hirschsprung’s Disease (HD) is by resection of the aganglionic segment of the distal intestine and bringing down the ganglionic segment by Modified Duhamel’s procedure or other pull-through operations. The assessment of the postoperative functional outcome and continence scoring systems are important considerations during follow-up of these children. In the present study, a scoring system was used to analyse the postoperative functional outcome of HD as there are very few studies, that have objectively assessed the same. Aim: To assess the functional outcome in children under six years of age, who underwent Modified Duhamel’s procedure for HD. Materials and Methods: This descriptive longitudinal, study was conducted in the Tertiary Teaching Institution at Government Medical College, Thiruvananthapuram, Kerala, India. The duration of the study was one year and nine months, from February 2017 to November 2018. Forty cases of biopsy proven HD, who underwent Modified Duhamel’s procedure were analysed. Postoperative follow-up was done at one, two, and three years after the definitive surgical procedure. Patients were classified as good, fair and poor outcome groups depending based on the Taylor-Duthies-Zachary continence scoring system. Statistical analysis was performed using Statistical Package for Social Sciences (SPSS) version 22.0. Pretest comparison of scores and p-value were analysed by Wilcoxon signed-rank test. A p-value <0.05 was considered as statistically significant. Results: The mean age of the study participants was 12.7±4.1 months and age ranges from three to 25 months. Median stool frequency per day after one, two, and three years of surgery, was 6.0, 4.0, and 3.0, respectively. The observed difference in median frequency between one and two year, one and three, and two year and three year was statistically significant (p<0.05). Median continence score to assess the anal sphincter control at one, two and three years after surgery were 2.3, 4.0 and 4.5, respectively. The observed difference in scores over successive years, was statistically significant (p<0.05). Conclusion: The functional outcome in patients, who underwent Duhamel’s procedure was good and the postoperative issues like increased stool frequency, and sphincter control improved over successive years.

Probiotics and synbiotics in chronic constipation in adults: A systematic review and meta-analysis of randomized controlled trials

Probiotics and synbiotics have been increasingly investigated for the management of chronic constipation. We aimed to investigate the effect of probiotics and synbiotics on stool output, gut transit time, symptoms and quality of life in adults with chronic constipation via a systematic review and meta-analysis of randomized controlled trials (RCTs). Studies were identified using electronic databases, backward citation and hand-searching abstracts. The search date was 10 July 2022. RCTs reporting administration of probiotics or synbiotics in adults with chronic constipation were included. Risk of bias (RoB) was assessed with the Cochrane RoB 2.0 tool. Meta-analysis was conducted separately for probiotics and synbiotics. Results were synthesized using risk ratios (RRs), mean differences or standardized mean differences (SMDs) and 95% confidence intervals (CIs) using a random-effects model. Thirty RCTs investigating probiotics and four RCTs investigating synbiotics were included. Overall, 369/647 (57%) responded to probiotic treatment and 252/567 (44%) to control (RR 1.28, 95% CI 1.07, 1.52, p=0.007). Probiotics increased stool frequency (SMD 0.71, 95% CI 0.37, 1.04, p<0.00001), with Bifidobacterium lactis having a significant effect, but not mixtures of probiotics, Bacillus coagulans Unique IS2 or Lactobacillus casei Shirota. Probiotics did not impact stool consistency (SMD 0.26, 95% CI-0.03, 0.54, p=0.08). Probiotics improved integrative symptom scores compared to control (SMD -0.46, 95% CI-0.89,-0.04). Synbiotics did not impact stool output or integrative symptom scores compared to control. Certain probiotics may improve response to treatment, stool frequency and integrative constipation symptoms, providing cautious optimism for their use as a dietary management option. There is currently insufficient evidence to recommend synbiotics in the management of chronic constipation. Caution is needed when interpreting these results due to high heterogeneity and risk of bias amongst the studies.

S713 Induction and Maintenance Treatment with Risankizumab Leads to Symptomatic Relief in Patients With Moderate to Severe Crohn’s Disease

S713 Induction and Maintenance Treatment with Risankizumab Leads to Symptomatic Relief in Patients With Moderate to Severe Crohn’s Disease

The Effect of Fiber Supplementation on Chronic Constipation in Adults: An Updated Systematic Review and Meta-Analysis of Randomized Controlled Trials

ABSTRACTBackgroundChronic constipation is a prevalent disorder that remains challenging to treat. Studies suggest increasing fiber intake may improve symptoms, although recommendations on the fiber type, dose, and treatment duration are unclear.ObjectivesWe investigated the effects of fiber supplementation on stool output, gut transit time, symptoms, and quality of life in adults with chronic constipation via a systematic review and meta-analysis of randomized controlled trials (RCTs).MethodsStudies were identified using electronic databases, backward citation, and hand searches of abstracts. RCTs reporting administration of fiber supplementation in adults with chronic constipation were included. Risks of bias (RoB) was assessed with the Cochrane RoB 2.0 tool. Results were synthesized using risk ratios (RRs), mean differences, or standardized mean differences (SMDs) and 95% CIs using a random-effects model.ResultsSixteen RCTs with 1251 participants were included. Overall, 311 of 473 (66%) participants responded to fiber treatment and 134 of 329 (41%) responded to control treatment [RR: 1.48 (95% CI: 1.17, 1.88; P = 0.001); I2 = 57% (P = 0.007)], with psyllium and pectin having significant effects. A higher response to treatment was apparent in fiber groups compared to control groups irrespective of the treatment duration, but only with higher fiber doses (>10 g/d). Fiber increased stool frequency [SMD: 0.72 (95% CI: 0.36, 1.08; P = 0.0001); I2 = 86% (P < 0.00001)]; psyllium and pectin had significant effects, and improvement was apparent only with higher fiber doses and greater treatment durations (≥4 weeks). Fiber improved stool consistency (SMD: 0.32; 95% CI: 0.18, 0.46; P < 0.0001), particularly with higher fiber doses. Flatulence was higher in fiber groups compared to control groups(SMD: 0.80; 95% CI: 0.47, 1.13; P < 0.00001).ConclusionsFiber supplementation is effective at improving constipation. Particularly, psyllium, doses >10 g/d and treatment durations of at least 4 weeks appear optimal, though caution is needed when interpreting the results due to considerable heterogeneity. These findings provide promising evidence on the optimal type and regime of fiber supplementation, which could be used to standardize recommendations to patients. The protocol for this review is registered at PROSPERO as CRD42020191404.

Patient-Reported Outcomes Correlate With Microbial Community Composition Independent of Mucosal Inflammation in Pediatric Inflammatory Bowel Disease.

Inflammatory bowel diseases (IBDs) involve an aberrant host response to intestinal microbiota causing mucosal inflammation and gastrointestinal symptoms. Patient-reported outcomes (PROs) are increasingly important in clinical care and research. Our aim was to examine associations between PROs and fecal microbiota in patients 0 to 22 years of age with IBD. A longitudinal, prospective, single-center study tested for associations between microbial community composition via shotgun metagenomics and PROs including stool frequency and rectal bleeding in ulcerative colitis (UC) and abdominal pain and stool frequency in Crohn's disease (CD). Mucosal inflammation was assessed with fecal calprotectin. A negative binomial mixed-effects model including clinical characteristics and fecal calprotectin tested for differentially abundant species and metabolic pathways by PROs. In 70 CD patients with 244 stool samples, abdominal pain correlated with increased relative abundance of Haemophilus and reduced Clostridium spp. There were no differences relative to calprotectin level. In 23 UC patients with 76 samples, both rectal bleeding and increased stool frequency correlated with increased Klebsiella and reduced Bacteroides spp. Conversely, UC patients with lower calprotectin had reduced Klebsiella. Both UC and CD patients with active symptoms exhibited less longitudinal microbial community stability. No differences in metabolic pathways were observed in CD. Increased sulfoglycolysis and ornithine biosynthesis correlated with symptomatic UC. Microbial community composition correlated with PROs in both CD and UC. Metabolic pathways differed relative to PROs in UC, but not CD. Data suggest that microbiota may contribute to patient symptoms in IBD, in addition to effects of mucosal inflammation.

Measurement of Disease Activity of Pouchitis.

Pouchitis is the most common inflammatory complication in ulcerative colitis patients undergoing postoperative construction of an IPAA. Pouchitis refers to a spectrum of diseases, and as such, it lacks a universally accepted definition as well as validated instruments to measure disease activity and treatment response. Assessing pouchitis activity is challenging, and methods for diagnosis and classification of severity of pouchitis are not universally agreed upon. Pouchitis is characterized by a constellation of clinical symptoms, including increased stool frequency, urgency, incontinence, bleeding, and rarely constitutional symptoms such as malaise and low-grade fever. However, these symptoms are subjective, and similar symptoms can be caused by noninflammatory conditions including anal sphincter dysfunction, anastomotic strictures, occult leaks, pouch inlet obstruction, and cuffitis. Objective scores that include endoscopic and histologic criteria have been developed for subjects with an IPAA. However, these instruments are not validated for measuring pouchitis disease activity and are associated with a number of challenges. In addition, the clinical components of the scores correlate poorly with endoscopic and histologic findings. There is a need for prospective studies to facilitate the development and validation of novel instruments that are valid, reliable, and responsive to change that would facilitate the development of therapeutic agents for the treatment of pouchitis.

Management of Acute and Chronic Pouchitis.

Restorative proctocolectomy with IPAA is the procedure of choice when colectomy is needed for medically refractory ulcerative colitis. Pouchitis is one of the most common complications among patients who have undergone IPAA and represents a spectrum of disease varying in both phenotype and clinical course. This study aimed to assist clinicians and surgeons in the treatment of both acute and chronic pouchitis, including newer therapies and future directions. Diagnosis is made by endoscopy of the pouch with biopsy because other conditions may produce similar symptoms such as increased stool frequency, abdominal cramps, and urgency. Pouchitis is classified by duration (acute versus chronic), disease pattern (infrequent, relapsing, and continuous), and response to antibiotics (responsive, dependent, and refractory). The Pouchitis Disease Activity Index may be used to measure disease activity. The management of pouchitis is guided by the disease phenotype. Acute episodes are treated with an initial 2-week course of antibiotics (typically ciprofloxacin or metronidazole), although patients with relapsing or chronic pouchitis may require long-term antibiotic treatment or the cycling of different antibiotics. Certain probiotics may also be used for maintenance therapy in those with chronic symptoms. For patients with chronic antibiotic refractory pouchitis, oral budesonide, immunosuppressive agents (azathioprine), or biologic therapy (infliximab, adalimumab, vedolizumab, and ustekinumab) may be required for both induction and maintenance with close monitoring for potential side effects. In rare cases, diverting ileostomy or pouch excision may be required. Pouchitis represents a spectrum of disease phenotypes, ranging from acute antibiotic responsive pouchitis to chronic antibiotic refractory pouchitis. The management of pouchitis is primarily directed by the disease phenotype.

Efficacy of Newly Developed Kombucha-Based Specialized Food Product for Treatment of Constipation-Predominant Irritable Bowel Syndrome

ObjectivesAim: to assess the efficacy of kombucha-based specialized food product, enriched with inulin in patients with constipation-predominant irritable bowel syndrome.MethodsThe study (NCT05164861) was approved by LEC and enrolled subjects with constipation-predominant irritable bowel syndrome (according to ROME IV). The subjects were randomized to receive either 220 ml of a non-alcoholic drink, based on pasteurized kombucha (KG), enriched with inulin (1.15 g/100ml) or 220 ml water (control group, CG), for 10 days. Except study product, subjects were advised to follow their usual diet. Standard examination included evaluation of stool frequency (bowel movements per day), stool form (with the Bristol stool scale) and evaluation of concomitant symptoms (abdominal pain/discomfort, abdominal fullness, bloating, and feeling of incomplete bowel emptying) with the use of 5-point Likert scale before (BL) and 10 days after the start of intervention (EOT).ResultsThe complete data of 40 subjects were available for the analysis. Significant increase of stool frequency was found at the EOT compared to BL in KG (n = 20), Mean ± SD: 0.60 ± 0.31 to 0.85 ± 0.19 times/day; p = 0.004, while there was no change in CG (n = 20): 0.63 ± 0.33 vs 0.72 ± 0.28, p > 0.05. Mean values of stool scale form increased in KG (2.95 ± 1.15 to 4.4 ± 0.97; p = 0.001), while remained unchanged in CG (2.94 ± 1.2 vs 3.4 ± 1.2, p = 0.6). Mean values of the Bristol stool scale in KG and CG differed significantly at EOT (p = 0.018). Significant decrease in mean values of incomplete bowel emptying feeling was found in KG (1.88 ± 0.78 at BL vs 1.41 ± 0.56 points at EOT, p = 0.015), but not in the control group. There was no difference in patient's reports for other symptoms between KG and CG.ConclusionsNew specialized kombucha-based drink enriched with inulin is well-tolerated and increases stool frequency and consistency in patients with constipation-predominant irritable bowel syndrome.Funding SourcesRussian Science Foundation (research grant # 19-76-30,014).

Diarrheal Illness

Diarrhea, qualitatively defined as an increase in stool frequency and liquid content, is a frequent complaint in patients presenting to emergency departments. Although most cases are uncomplicated viral infections, the most frequent causes of dangerous underlying entities are often not viral. In uncomplicated cases, laboratory testing for metabolic derangements is not required unless there are signs of moderate to severe dehydration or the patient has particular risks, such as chronic kidney disease. Secondary infections associated with antibiotic use (C difficile–associated diarrhea), other significant nosocomial exposures, recent international travel history, the presence of a nonintact immune system (HIV/AIDS, cancer/chemotherapy), and exposure to high-risk environments (including zoonotic exposures, outbreak-prone environments such as day care facilities) increase the likelihood of a bacterial or other infectious cause requiring either microbiologic testing or empirical antimicrobial treatments. Diarrhea is often present as a feature of clinically significant noninfectious conditions, including complications of inflammatory bowel diseases (Crohn disease and ulcerative colitis), overdoses, and withdrawal syndromes. In such cases, after hemodynamic stability has been ensured, advanced workup and treatment are guided by the underlying condition and antecedent risks, not the presence of diarrhea per se. Oral rehydration is the first step in management for mild dehydration caused by uncomplicated diarrhea. Intravenous fluids may be necessary in moderate to severe dehydration and in cases of electrolyte derangement requiring resuscitation where fluid choice and rate are paramount, as well as in patients who cannot tolerate oral intake. In cases of suspected bacteria-caused diarrhea, antibiotics, most often fluoroquinolones, reduce both the severity and duration of illness. In patients safe for home management, antidiarrheal agents such as loperamide may be used in uncomplicated and resolving cases. Probiotics appear safe in most cases and impart a small but clinically detectable decrease in the duration and severity of illness. Although there have been fears of bacterial outbreaks following natural disasters, improvements in local and global health efforts have led to decreases in cholera outbreaks, and typical viral causes of diarrhea are generally the most common causes. This review contains 4 figures, 5 tables and 32 references Key words: Clostridium difficile, diarrhea, infectious diseases, inflammatory bowel diseases, medication side effects, overdose syndromes, sepsis, traveler’s diarrhea, zoonotic infections

Diarrheal Illness

Diarrhea, qualitatively defined as an increase in stool frequency and liquid content, is a frequent complaint in patients presenting to emergency departments. Although most cases are uncomplicated viral infections, the most frequent causes of dangerous underlying entities are often not viral. In uncomplicated cases, laboratory testing for metabolic derangements is not required unless there are signs of moderate to severe dehydration or the patient has particular risks, such as chronic kidney disease. Secondary infections associated with antibiotic use (C difficile–associated diarrhea), other significant nosocomial exposures, recent international travel history, the presence of a nonintact immune system (HIV/AIDS, cancer/chemotherapy), and exposure to high-risk environments (including zoonotic exposures, outbreak-prone environments such as day care facilities) increase the likelihood of a bacterial or other infectious cause requiring either microbiologic testing or empirical antimicrobial treatments. Diarrhea is often present as a feature of clinically significant noninfectious conditions, including complications of inflammatory bowel diseases (Crohn disease and ulcerative colitis), overdoses, and withdrawal syndromes. In such cases, after hemodynamic stability has been ensured, advanced workup and treatment are guided by the underlying condition and antecedent risks, not the presence of diarrhea per se. Oral rehydration is the first step in management for mild dehydration caused by uncomplicated diarrhea. Intravenous fluids may be necessary in moderate to severe dehydration and in cases of electrolyte derangement requiring resuscitation where fluid choice and rate are paramount, as well as in patients who cannot tolerate oral intake. In cases of suspected bacteria-caused diarrhea, antibiotics, most often fluoroquinolones, reduce both the severity and duration of illness. In patients safe for home management, antidiarrheal agents such as loperamide may be used in uncomplicated and resolving cases. Probiotics appear safe in most cases and impart a small but clinically detectable decrease in the duration and severity of illness. Although there have been fears of bacterial outbreaks following natural disasters, improvements in local and global health efforts have led to decreases in cholera outbreaks, and typical viral causes of diarrhea are generally the most common causes. This review contains 4 figures, 5 tables and 32 references Key words: Clostridium difficile, diarrhea, infectious diseases, inflammatory bowel diseases, medication side effects, overdose syndromes, sepsis, traveler’s diarrhea, zoonotic infections

Common Genetic Variants in the Bile Acid Synthesis Enzyme CYP7A1 Are Associated With Severe Primary Bile Acid Diarrhea

Bile acid diarrhea (BAD) is increasingly recognized as a common cause of chronic bowel disorders including increased stool frequency, urgency, and incontinence, overlapping with irritable bowel syndrome with diarrhea and functional diarrhea.1 BAD can be diagnosed by measurement of fecal bile acids (BAs), the 75-selenium homocholic acid taurine (SeHCAT) retention nuclear medicine test and biomarkers where available, or by therapeutic response.1 Idiopathic, primary BAD occurs in 25%–33% of patients presenting with chronic diarrhea, giving a population prevalence estimate of approximately 1%.

Factors associated with the prescription of probiotics in patients with inflammatory bowel disease: a cross-sectional study.

Commensal bacteria play an important role in the pathogenesis of inflammatory bowel disease (IBD) and probiotics have been used as treatment options. We aimed to explore the current use of probiotics and factors associated with their prescription in patients with IBD. This cross-sectional study was conducted on a single hospital-based cohort. Patients were eligible if they were ≥18 years old, visited the IBD clinic as an outpatient more than twice during the study period, and had a confirmed diagnosis of IBD. Patients were divided into two groups based on the prescription of probiotics. Clinical assessments were compared between the two groups. In total, 217 patients were enrolled in this study. In patients with Crohn disease (CD), moderate or severe abdominal pain; prior use of methotrexate (MTX), iron, thiopurines, or biologics; history of IBD-related surgery; and stool frequency were independently associated with the prescription of probiotics. In patients with ulcerative colitis (UC), moderate or severe abdominal pain, hematochezia, stool frequency, and moderate or severe physician global assessment score were independently associated with the prescription of probiotics. Increased disease activity may be associated with fewer prescriptions of probiotics in patients with IBD. However, physicians prescribed probiotics to control symptoms, such as abdominal pain and increased stool frequency in patients with UC and CD, and hematochezia in patients with UC. Additionally, the use of MTX and iron, and a history of IBD-related surgeries were associated with more frequent probiotic prescriptions in patients with CD.

A Double-Blind, Randomized Intervention Study on the Effect of a Whey Protein Concentrate on E. coli-Induced Diarrhea in a Human Infection Model.

Infectious diseases are a major cause of morbidity and mortality worldwide. Nutritional interventions may enhance resistance to infectious diseases or help to reduce clinical symptoms. Here, we investigated whether a whey protein concentrate (WPC) could decrease diarrheagenic Escherichia coli-induced changes in reported stool frequency and gastrointestinal complaints in a double-blind, parallel 4-week intervention study. Subjects were randomly assigned to a whey hydrolysate placebo group, a low-dose WPC group or a high-dose WPC group. After 2 weeks of consumption, subjects (n = 121) were orally infected with a high dose of live but attenuated diarrheagenic E. coli (strain E1392/75-2A; 1E10 colony-forming units). Subjects recorded information on stool consistency and the frequency and severity of symptoms in an online diary. The primary outcome parameters were a change in stool frequency (stools per day) and a change in Gastrointestinal Symptom Rating Scale (GSRS) diarrhea score between the first and second days after infection. Neither dose of the whey protein concentrate in the dietary treatment affected the E. coli-induced increase in stool frequency or GSRS diarrhea score compared to placebo treatment. The composition of the microbiota shifted between the start of the study and after two weeks of consumption of the products, but no differences between the intervention groups were observed, possibly due to dietary guidelines that subjects had to adhere to during the study. In conclusion, consumption of the whey protein concentrate by healthy adults did not reduce diarrhea scores in an E. coli infection model compared to a whey hydrolysate placebo control.

A pilot randomized placebo-controlled study on modified MaZiRenWan: a formulated Chinese medicine to relieve constipation for palliative cancer patients

BackgroundConstipation is a common problem among advanced cancer patients; however, many of them find limited effective from current therapies. Thus, we aimed to test the effect of a traditional Chinese herbal formula, modified MaZiRenWan (MZRW), by comparing with placebo among palliative cancer patients with constipation.MethodsThis is a randomized, double-blind, placebo-controlled trial. Participants aged over 18 were recruited and randomized to MZRW or placebo group in addition to current prescriptions (including ongoing laxatives treatment) for two weeks. Exclusion criteria included cognitive impairment, presence of a colostomy or gastrointestinal obstruction and estimated life expectancy of less than one month. Individualized modification of MZRW was allowed according to the traditional Chinese medicine (TCM) pattern of patient. The primary outcome was the global assessment of improvement, which reflected whether the constipation had improved, remained the same or worsened.ResultsSixty patients, with mean age 75.2 years (range 47–95 years), were randomized to MZRW or placebo group. Among the MZRW group, 59.3% (16/27) had improvement in the global assessment score, as compared with 28.6% (8/28) of the placebo group (p-value = 0.022). Besides, the MZRW group had significant increase in stool frequency, and reduction in constipation severity and straining of defecation (p-value < 0.05). No serious adverse event was reported due to the research medication.ConclusionThis pilot trial suggests modified MZRW is well-tolerated and effective for relief of constipation in patients with advance cancer. It could be considered as a potential treatment option for constipation in palliative care.Trial registration: The trial had been registered in ClinicalTrials.gov with identifier number NCT02795390 [https://clinicaltrials.gov/ct2/show/NCT02795390] on June 10, 2016.

P087 Communicating Needs and Features of IBD Experiences (CONFIDE) Survey: Impact of Ulcerative Colitis Symptoms on Daily Life

Abstract Background Bowel urgency is the symptom described by patients as having the most impact on quality of life but is missing from most disease activity indices (Carpio et al., 2016). The Communicating Needs and Features of IBD Experiences (CONFIDE) study aims to increase understanding of patients’ experiences and the impact of IBD on their lives in the United States (US), Europe, and Japan. These data focus on US patients with moderately-to-severely active ulcerative colitis (UC). Methods An online, quantitative, cross-sectional survey was conducted with patients with moderately-to-severely active UC in the US in July 2021. Data included patient perspectives on their UC symptoms and the impact on their social life, work/school life, and ability to participate in sports/physical activities. Moderately-to-severely active UC was defined based on treatment, steroid use, and/or hospitalization history. Descriptive statistics (frequencies, percentages) summarise the data. Results 200 (of 756 total contacted) patients (61.5% male, mean age 40.4, mean disease duration 7.9 years) completed the survey in the US, with 77% (n=153) of patients receiving advanced therapies (biologic or novel oral therapy). Patients declined participation in social events due to bowel urgency (43%), fear of urge incontinence (40%), increased stool frequency (29%), and blood in stool (15%) in the last three months (Fig. 1). Patients declined participation in sports/physical exercise due to bowel urgency (38%), fear of urge incontinence (36%), increased stool frequency (24%), and blood in stool (10%) in the last three months (Fig. 2). Patients declined participation in work/school due to bowel urgency (37%), fear of urge incontinence (42%), increased stool frequency (25%), and blood in stool (16%) in the last three months (Fig. 3). Out of 123 patients who have ever suffered from bowel urgency, in the last three months 42% stopped working for the day sooner than planned and 41% worked fewer hours. Notably, 76% of patients reported wearing a diaper/pad/protection at least once in the last three months due to fear of urge incontinence. Bowel urgency had no impact on work/school for 22% (n=27) of patients who had ever experienced bowel urgency (Fig. 4). Conclusion Bowel urgency and fear of urge incontinence are the most reported symptoms leading to patients with UC declining participation in work/school, social events, and sports/physical exercise. Over three quarters of the surveyed patients reported wearing diapers/pads/protection in the past three months due to fear of urge incontinence and only 22% of patients who had ever suffered from bowel urgency reported that it had no impact on work or school.

Effects of Elobixibat on Constipation and Lipid Metabolism in Patients With Moderate to End-Stage Chronic Kidney Disease.

Objective:The aim of this study was to investigate the effects of elobixibat on constipation and lipid metabolism; and determine the factors associated with the effect of elobixibat on constipation in patients with moderate to end-stage chronic kidney disease (CKD).Methods:Stool frequency and serum lipid parameters were retrospectively analyzed before and after 4 weeks of elobixibat administration in 42 patients (CKD stage G3, 6; stage G4, 9; stage G5, 9; stage G5D, 18). Relationships between the change in stool frequency after initiation of elobixibat and various clinical parameters were analyzed by using linear regression analysis.Results:Elobixibat increased stool frequency from 0.5 ± 0.4 per day to 1.1 ± 0.6 per day (p < 0.001) regardless of whether patients were undergoing dialysis, on concomitant laxatives, or were administered elobixibat before or after breakfast. Elobixibat reduced low-density lipoprotein cholesterol concentration (from 90.9 ± 37.2 mg/dL to 77.5 ± 34.8 mg/dL, p < 0.05) and increased high-density lipoprotein cholesterol concentration (from 44.9 ± 14.3 mg/dL to 57.0 ± 25.8 mg/dL, p < 0.05), but did not change triglyceride concentration. Adverse effects were observed in two patients (nausea and diarrhea). Only phosphate concentration was correlated with the change in stool frequency after initiation of elobixibat (standard coefficient = 0.321, p = 0.043).Conclusions:Elobixibat improved constipation and lipid metabolism in patients with moderate to end-stage CKD, without serious adverse events.

Prebiotic Galacto-Oligosaccharides Impact Stool Frequency and Fecal Microbiota in Self-Reported Constipated Adults: A Randomized Clinical Trial.

Constipation is a major issue for 10–20% of the global population. In a double-blind randomized placebo-controlled clinical trial, we aimed to determine a dose-response effect of galacto-oligosaccharides (GOS) on stool characteristics and fecal microbiota in 132 adults with self-reported constipation according to Rome IV criteria (including less than three bowel movements per week). Subjects (94% females, aged: 18–59 years) received either 11 g or 5.5 g of BiotisTM GOS, or a control product, once daily for three weeks. Validated questionnaires were conducted weekly to study primarily stool frequency and secondary stool consistency. At base- and endline, stool samples were taken to study fecal microbiota. A trend towards an increased stool frequency was observed after the intervention with 11 g of GOS compared to control. While during screening everybody was considered constipated, not all subjects (n = 78) had less than three bowel movements per week at baseline. In total, 11 g of GOS increased stool frequency compared to control in subjects with a low stool frequency at baseline (≤3 bowel movements per week) and in self-reported constipated adults 35 years of age or older. A clear dose-response of GOS was seen on fecal Bifidobacterium, and 11 g of GOS significantly increased Anaerostipes hadrus. In conclusion, GOS seems to be a solution to benefit adults with a low stool frequency and middle-aged adults with self-reported constipation.

Effects of a Food Supplement with a Wild Thyme (&amp;lt;i&amp;gt;Thymus serpyllum&amp;lt;/i&amp;gt; L.) Extract on Gut Health and the Microbiome in Humans: A Randomized, Double-Blinded, Placebo-Controlled Clinical Trial

Background: Based on the scientific and traditional knowledge, benefits for gut and digestive health were expected from Wild Thyme (Thymus serpyllum L.) extract (WThE) consumption, but no controlled human studies were performed yet to prove the proposed health benefits. Method: The aim of this human randomized, double-blind parallel arm pilot study was to explore the impact of aqueous Wild Thyme extract, a food supplement, in a healthy but overweight study collective (N = 40). In detail, the impact on digestion, gastrointestinal symptoms, gut microbiome, and quality of life by employing an essential oil-free WThE preparation or a matching placebo was investigated. Results: The study results indicate that WThE has the potential to improve gastrointestinal symptoms and increase stool frequency, thus an improved quality of life was observed. The stool microbiome of study collective was characterized by a high Firmicutes to Bacteroidetes ratio. A decrease in the mean Firmicutes/Bacteroidetes ratio was seen in WThE group. Conclusion: The data support the potential applications of WThE as a food supplement with benefits on gut health.

Clinical and metabolic effects of metaprebiotic therapy for some functional bowel diseases

Aim of investigation: to assess the effectiveness and tolerance of dietary supplements (BAA) STIM and STIM LaxMaterials and methods: The analysis of the treatment of 73 patients who were divided into 2 groups. Group 1-32 patients with functional constipation (8 men and 24 women; mean age — 45.7 ± 12.4 years), Group 2-41 patients with functional diarrhea (19 men and 22 women; mean age — 41.0 ± 15,8 years). The study of clinical symptoms was carried out according to the data of an individual diary, using specialized questionnaires with a scoring of symptoms before and after the course of treatment, before and after treatment, the result of the carbolene test, the content of short-chain fatty acids in the feces was assessed. Tolerability was assessed by recording side effects and adverse events.Monotherapy was carried out with STIM LAX for patients with functional constipation at a dose of 1 tablet 3 times a day for 30 days. STIM for patients with functional diarrhea was prescribed in a dose of 2 tablets 3 times a day for 30 days.Results of the study: The results of the study showed that FC therapy with StimLax effectively reduces the frequency and intensity of symptoms such as difficulty / pain, discomfort during defecation, feeling of incomplete emptying, abdominal pain, time spent in the toilet and the number of failed bowel movements. We observed the normalization of transit time according to the carbolene test and an increase in stool frequency up to 5 times a week.Treatment of patients with FD with Stim led to a significant decrease in the intensity of abdominal pain, rumbling, flatulence, stool frequency, an increase in the time of the carbolene test and the normalization of its consistency.Adverse events were observed in 8 (10.9%) patients (4 patients with FD and 4 patients with FD). On the 3-5th day of treatment, there was an increase in flatulence, rumbling in the abdomen. A temporary decrease in the dose of the drug to 1-2 tablets per day removed these phenomena and the symptoms that appeared were resolved within 1-3 days. After that, the dose of the drug was gradually increased to the initial (effective), which the patients tolerated normally.Conclusions: The results of this study indicate high clinical efficacy and good tolerability of treatment with drugs StimLax and Stim in patients with FC and FD. In some cases, it is necessary to titrate the dose of the drug (downward), but this is not accompanied by a decrease in the effectiveness of therapy. The use of these drugs with metaprebiotic properties helps to modify the microbiota of patients with functional bowel diseases. With constipation, the number and activity of both lactic acid flora and microorganisms that produce butyric acid are stimulated; in addition, calcium lactate is an additional source of butyric acid due to metabolism. With diarrhea, along with the stimulation of the number and activity of the lactic acid flora, there is an improvement in the utilization of butyrate by intestinal cells.