Gastrointestinal Symptom Scores Research Articles

The Efficacy and Safety of NOVAponin (Dolichos lablab Linne Extract Powder) in Mild Functional Dyspepsia: A Single-center, Randomized, Double-Blind, Placebo-controlled Study.

NOVAponin, a functional health food derived from Dolichos lablab Linne extract improves gastric mucosal injury and increases regeneration and proliferation. This study aims to investigate the efficacy and safety of NOVAponin in individuals with mild functional dyspepsia (FD). In this single-center, double-blind, randomized clinical trial, 131 patients with FD meeting the Rome IV criteria were enrolled. Changes in the gastrointestinal symptom rating scale (GSRS), FD-related quality of life (FD-QoL), gastrointestinal symptom (GIS) scores, inflammatory and anti-inflammatory markers, and adverse effects before and after administration were compared. After 12 weeks of administration, GSRS upper abdominal symptom scores were significantly improved in the test group compared to the control group (-5.30 ± 0.60 vs -2.35 ± 0.56, P < 0.001). GSRS upper abdominal symptom scores (-5.13 ± 0.55 vs -1.92 ± 0.44, P < 0.001), GSRS total scores (-7.02 ± 0.91 vs -3.33 ± 0.73, P < 0.001), GIS total scores (-11.21 ± 0.53 vs -6.65 ± 0.70, P < 0.001) after 6 weeks of administration, GSRS total scores (-7.54 ± 0.94 v. -3.31 ± 0.85, P < 0.001), GIS total scores (-11.90 ± 0.52 vs -7.61 ± 0.73, P < 0.001), and FD-QoL total scores (-11.41 ± 1.75 vs -5.55 ± 1.20, P = 0.007) after 12 weeks of administration also showed significant differences between groups. The differences were slightly more pronounced in epigastric pain syndrome subtypes and in females than the others, although more females were assigned to the test group. There were no significant changes in inflammatory and anti-inflammatory markers or adverse reactions. NOVAponin significantly improved mild FD symptoms especially in epigastric pain syndrome subtype and in females, and was found to be safe.

The impact of a whole foods dietary intervention on gastrointestinal symptoms, inflammation, and fecal microbiota in pediatric patients with cystic fibrosis: A pilot study

Gastrointestinal (GI) complications are a significant source of morbidity for people with cystic fibrosis (PwCF). Historically, dietary recommendations in CF have focused on calories, typically emphasizing a high fat diet. The changing landscape of CF highlights the need to update this nutritional strategy. There is little research into how the quality of calories consumed by PwCF influences nutritional outcomes, GI symptoms, or likely contributors: intestinal inflammation and GI microbiology. We assessed the feasibility of a whole foods-based diet (WFD) and avoidance of ultra-processed foods, measuring safety/tolerability, adherence, and GI symptoms, as well as fecal measures of inflammation and microbiota among children with CF (CwCF) with GI symptoms. Single center, 4-week dietary intervention involving CwCF aged 5-14 years who screened positive on GI symptom questionnaire. Assessments included weight, symptom questionnaires and adverse events (AEs). Stool was analyzed for microbiota (16S rRNA) and calprotectin. 108 children were pre-screened, 9 enrolled and 8 initiated and completed the study. There were no significant changes in weight and no AEs. PEDS-QL GI identified overall improvement in symptoms. Certain symptom domains (constipation, diarrhea, gas/bloating, stomach pain and hurt) demonstrated significant improvement on the WFD. Of two participants with abnormal fecal calprotectin at enrollment, both exhibited decreased values on WFD. There was no significant change in microbiota diversity. A WFD diet was feasible and safe in CwCF. There was improvement in GI symptom scores based on both parent and child assessments. Larger studies are needed to further investigate effects on intestinal inflammation and microbiota.

Disaccharidase deficiencies and gastrointestinal symptoms in patients referred to gastroscopic examination: a single center study from Norway

Objective Gastrointestinal illnesses have been reported in relation to low disaccharidase activity, yet both the prevalence of disaccharidase deficiency and its association with gastrointestinal symptoms and irritable bowel syndrome (IBS) are largely unknown. We aimed to determine the association between low activity of disaccharidase enzymes on gastrointestinal symptoms and presence of IBS. Methods Patients referred for gastroscopic examination due to gastrointestinal complaints were consecutively included. A pinch biopsy was taken from the distal part of duodenum, and disaccharidase activity was measured using the Dahlqvist method. Gastrointestinal symptom severity was measured using IBS-Symptom Severity Score (IBS-SSS). Results A total of 40 patients were included. Disaccharidase deficiency was detected in 24 patients (60%). Half of the patients (n = 21) had IBS according to Rome IV criteria. A majority (75%) of all patients reported moderate to severe gastrointestinal symptoms. Moderate to severe gastrointestinal symptoms were reported by 16 patients (67%) with disaccharidase deficiency and in 14 patients (88%) with normal disaccharidase activity. Lactase deficiency was detected in 22 patients (55%), maltase deficiency in 11 patients (28%), sucrase deficiency in 9 patients (23%), isomaltase deficiency in 13 patients (33%) and glucoamylase deficiency in 12 patients (30%). The activity of all enzymes was reduced in 8 patients (20%). Degree of disaccharidase deficiency was not associated with either the severity of gastrointestinal symptoms or the diagnosis of IBS. Enzymes levels were not associated with gastrointestinal symptom scores. Conclusion Our findings did not reveal any association between biochemically measured disaccharidase deficiency and gastrointestinal symptoms or the presence of IBS.

Decision Regret in Patients with Appendiceal Cancer Undergoing Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy.

Decision regret is an emerging patient reported outcome. The aim of this study was to assess the incidence of regret in patients with appendiceal cancer (AC) who underwent cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (CRS-HIPEC). An anonymous survey was distributed to patients through the Appendix Cancer and Pseudomyxoma Peritonei (ACPMP) Research Foundation. The Decision Regret Scale (DRS) was employed, with DRS > 25 signifying regret. Patient demographics, tumor characteristics, postoperative outcomes, symptoms (FACT-C), and PROMIS-29 quality of life (QoL) scores were compared between patients who regretted or did not regret (NO-REG) the procedure. A total of 122 patients were analyzed. The vast majority had no regret about undergoing CRS-HIPEC (85.2%); 18 patients expressed regret (14.8%). Patients with higher regret had: income ≤ $74,062 (72.2% vs 44.2% NO-REG; p = 0.028), major complications within 30 days of surgery (55.6% vs 15.4% NO-REG; p < 0.001), > 30 days hospital stay (38.9% vs 4.8% NO-REG; p < 0.001), a new ostomy (27.8% vs 7.7% NO-REG; p = 0.03), >1 CRS-HIPEC procedure (56.3% vs 12.6% NO-REG; p < 0.001). Patients with worse FACT-C scores had more regret (p < 0.001). PROMIS-29 QOL scores were universally worse in patients with regret. Multivariable analysis demonstrated > 30 days in the hospital, new ostomy and worse gastrointestinal symptom scores were significantly associated with regret. The majority of patients with AC undergoing CRS-HIPEC do not regret undergoing the procedure. Lower income, postoperative complications, an ostomy, undergoing > 1 procedure, and with worse long-term gastrointestinal symptoms were associated with increased regret. Targeted perioperative psychological support and symptom management may assist to ameliorate regret.

The influence of tramadol on bowel function: A randomised, placebo-controlled trial.

Tramadol is a weak opioid used to treat moderate pain. Stronger opioids inhibit gastrointestinal function, but little is known about the gastrointestinal effects of tramadol. Our aim was to investigate if tramadol causes opioid-induced bowel dysfunction (OIBD). Twenty healthy male participants (mean age 24 [range 20-31] years) were included. Tramadol (extended-release formulation, 200 mg/day) or placebo was administered for 10days in two study periods separated by 3weeks. Gastrointestinal transit times and segmental volume, motility and water content were investigated with the 3D-transit system and magnetic resonance imaging. Bowel movements and gastrointestinal symptoms were recorded daily. Tramadol prolonged colonic transit time (34 h vs. 25 h, p< 0.001) and increased small bowel motility (p< 0.01) and water content (p= 0.002) compared to placebo. Across all days of treatment, tramadol reduced the number of mean daily bowel movements (p= 0.001) and increased mean stool consistency (p= 0.006). Gastrointestinal symptom scores increased with tramadol (indigestion: +358%, p= 0.01; constipation: +475%, p= 0.01). Additionally, more participants fulfilled the diagnostic criteria for constipation after tramadol treatment compared to placebo (40% vs. 0%, p< 0.001). This study showed that tramadol treatment is associated with OIBD, and management of constipation and other bowel symptoms should, therefore, be prioritised when treating pain patients with tramadol.

Efficacy and safety of minodronate in the treatment of postmenopausal osteoporosis with low back pain: a single-centre, randomized and open-label controlled trial

BackgroundLow back pain is one of the most common symptoms of osteoporosis. The pain can seriously affect patients’ mood and quality of life; it can also further aggravate bone loss, causing a serious social burden. Minodronate is an oral bisphosphonate that needs to be administered daily. It significantly reduces levels of bone turnover markers (BTMs) and rapidly improves symptoms of low back pain in patients with osteoporosis. Osteoporosis requires long-term treatment, and daily dosing reduces patient compliance. Minodronate has a better safety profile than other bisphosphonates. The objective of the trial is to explore the efficacy and safety of minodronate in the treatment of low back pain in postmenopausal osteoporosis patients.MethodsThis is a single-centre, randomized, open-label controlled trial with a 24-week duration. Seventy-two eligible patients will be randomly divided into 4 groups. Subjects will be randomized at a 1:1 ratio to receive either minodronate (1 mg/day) or alendronate (10 mg/day) every day; senior women (≥ 75 years old) and older women (< 75 years old) will be at a ratio of 1:2. The primary outcome is the time required for the visual analogue scale (VAS) score to decline by ≥ 10 from baseline. The secondary outcome is the changes in VAS scores from baseline, the frequency and dosage of rescue medication, BTMs, bone mineral density (BMD), and variations in upper gastrointestinal (GI) symptom scores from baseline (including heartburn, pain, and bloating).DiscussionThis study will provide objective evidence for the efficiency and safety of minodronate. Furthermore, it will be helpful to evaluate the quantitative relationship between BTMs and BMD in patients with osteoporosis under different ages.Trial registrationThis study protocol has been registered with ClinicalTrials.gov ID NCT05645289 (https://clinicaltrials.gov/search?term=NCT05645289) on December 8, 2022. The registry name is Peking University Third Hospital. This study protocol was reviewed and approved by the Peking University Third Hospital Medical Science Research Ethics Committee (M2022465, 2022.08.09, V2.0). The results will be published in scientific peer-reviewed journals.Trial statusThe protocol was registered at ClinicalTrials.gov (registration number: NCT05645289). Recruitment has started in January 2023 and is still ongoing.

The effectiveness and safety of the anti gastroesophageal reflux system in the treatment of gastroesophageal reflux disease: a single center study of 23 cases

Objective: To evaluate the safety and efficacy of domestically produced magnetic sphincter augmentation (MSA) for gastroesophageal reflux disease. Method: This study is a prospective cohort study. Patients with typical heartburn and reflux symptoms (at least partial response to proton pump inhibitors), abnormal esophageal acid exposure and normal esophageal peristalsis were included, prospectively in the Department of Gastroesophageal Surgery, Rocket Force Characteristic Medical Center from June 2019 to September 2022. Patients with hiatal hernia >2 cm and severe esophagitis were excluded. The MSA was wrapped around the distal esophagus after esophageal hiatus repair by laparoscopy. A postoperative questionnaire survey was conducted to assess the relief of symptom, complications, the discontinuation rate of proton pump inhibitor, and surgical satisfaction. Gastroscopy, high-resolution esophageal pressure measurement, and pH value impedance monitoring were also reviewed. The pre- and postoperative rates were compared using the McNeinar χ2 test. Result: Currently, 23 patients with gastroesophageal reflux disease were enrolled and underwent MSA surgery. There were 20 males and 3 females, aged (M (IQR)) 48 (14) years (range: 25 to 64 years). All cases were successfully implanted with MSA. Subjective indicators were followed for 17 (18) months (range: 14 to 53 months), while objective indicators were followed for 17 (1) months (range: 12 to 23 months). The postoperative gastrointestinal and extraesophageal symptom scores showed a significant decrease compared to preoperative levels as follows: the degree of subjective relief of overall digestive symptoms was 90 (20)% (range:0~100%), the degree of subjective relief of overall respiratory symptoms was 100(10)% (range: 10%~100%), the overall satisfaction rate was 83% (19/23), the proton pump inhibitor discontinuation rate was 70% (16/23). The proportion of esophagitis has decreased from 44% (10/23) to 9% (2/23) (κ=0.169, P=0.039), The Hill grade of gastroesophageal valve morphology improved from 1 case of grade Ⅰ, 5 cases of grade Ⅱ, 10 cases of grade Ⅲ, and 7 cases of grade Ⅲ preoperative to 22, 1, 0, and 0 cases postoperative. The proportion of lower esophageal sphincter pressure below normal has decreased from 70% (16/23) to 35% (8/23) (κ=0.170, P=0.012). There were 21 patients who restored normal esophageal acid exposure. Eleven patients had mild long-term dysphagia, but it didn't affect their daily life. No postoperative device migration, erosion, or secondary surgical removal occurred. Conclusions: Laparoscopic implantation of the MSA device was safe and well tolerated. It can effectively control the symptoms of gastroesophageal reflux disease, reduce medication, restore normal cardia morphology and function, and esophageal acid exposure. The main postoperative complication was dysphagia, but it was relatively mild.

Joint Hypermobility, Autonomic Dysfunction, Gastrointestinal Dysfunction, and Autoimmune Markers: Clinical Associations and Response to Intravenous Immunoglobulin Therapy.

We examined autoimmunity markers (AIM) and autonomic dysfunction in patients with chronic neurogastroenterological symptoms and their relationship to joint hypermobility/hypermobility spectrum disorder (JH/HSD). AIM positivity was defined as a diagnosis of known autoimmune/autoinflammatory disorder with at least 1 positive seromarker of autoimmunity or at least 2 positive seromarkers by themselves. Three cohorts were studied: (i) retrospective (n = 300), (ii) prospective validation cohort (n = 133), and (iii) treatment cohort (n = 40), administered open-label intravenous immunoglobulin (IVIG). AIM positivity was found in 40% and 29% of the retrospective and prospective cohorts, the majority of whom (71% and 69%, respectively) had autoinflammatory disorder. Significantly more patients with AIM had elevations of C-reactive protein (31% vs 15%, P < 0.001) along with an increased proportion of cardiovascular autonomic dysfunction (48% vs 29%; P < 0.001), small fiber neuropathy (20% vs 9%; P = 0.002), and HLADQ8 positivity (24% vs 13%, P = 0.01). Patients with JH/HSD were more likely to have AIM (43% vs 15%, P = 0.001) along with more severe autonomic and gastrointestinal (GI) symptom scores. IVIG treatment was associated with robust improvement in pain, GI, and autonomic symptoms, but adverse events were experienced by 62% of patients. Autoimmune markers and autonomic dysfunction are common in patients with unexplained GI symptoms, especially in those with JH/HSD. Many patients seem to respond to IVIG treatment, but this needs to be confirmed by controlled trials. These results highlight the need for vigilance for autoimmune and autonomic factors and JH/HSD in patients with neurogastroenterological disorders. Clinicaltrials.gov , NCT04859829.

The effect of mindfulness-based cognitive therapy on the Clinical efficacy and psychological state in patients with functional dyspepsia

Background and Aim To observe the clinical therapeutic effect and mental state of mindfulness-based cognitive therapy (MBCT) in patients with functional dyspepsia (FD). Methods In this study, 80 patients suffering from FD in an outpatient clinic were enrolled from January to December 2020. Patients were randomly allocated into the control group (conventional treatment) and observation group (MBCT treatment). Patients in the control group were prescribed rabeprazole and mosapiride, and patients in the observation group were given MBCT therapy in addition to the above drugs. After treatment for 8 weeks, the changes in gastrointestinal symptom scores, anxiety, depression, mindfulness and sleep quality and gastric emptying testing were compared between these two groups. Results The observation group showed strikingly lower gastrointestinal symptom scores, SAS, SDS, PSQI, and SCL-90 scale scores, and higher FFMQ scale scores than the control group (p < 0.05). There was no conspicuous change in gastric emptying monitoring (p > 0.05). Conclusions MBCT therapy can improve patients’ gastrointestinal symptoms, attenuate their anxiety and depression levels, and ameliorate their sleep quality.

Double-blind, randomized, 8-week multicenter study of the efficacy and safety of STW 5-IIversus placebo in functional dyspepsia.

Herbal products are widely used to treat patients with disorders of gut brain interaction but clinical efficacy and safety data for treatments lasting >4 weeks are widely lacking. We evaluated the efficacy and safety of 8 weeks of treatment with the herbal combination product STW 5-II for patients with functional dyspepsia (FD) meeting Rome II criteria. We also conducted a post hoc analysis including patients meeting Rome IV criteria for FD and evaluated the effect of the G-protein beta 3 (GNB3) subunit polymorphism (C825T) on therapeutic response. This multicenter, placebo-controlled, double-blind study included 272 FD patients meeting Rome II criteria in the intention-to-treat cohort and 266 meeting Rome IV criteria. We used the validated Gastrointestinal Symptom Score (GIS) to assess GI symptoms, defining response rate as the proportion of patients with ≥50% GIS improvement in at least three of four assessments. After 8 weeks, the response rate was significantly higher in the STW 5-II group versus placebo (61.2% vs 45.1%, P = 0.008). Mean GIS non-significantly improved with STW 5-II treatment (7.9 ± 4.41 vs 6.7 ± 4.91 with placebo; P = 0.07). In the Rome IV subgroup analysis, STW 5-II yielded a better response rate (P = 0.01) versus placebo and greater postprandial distress symptom improvement (P = 0.04) versus placebo. Safety parameters did not differ between groups, and GNB3 status was not linked with therapeutic response. STW 5-II is efficacious, with no observed safety signals at up to 8 weeks of treatment in patients with FD meeting Rome II or IV criteria.

The GUTFIT Cohort: Understanding of different gastrointestinal symptoms score variation between Chinese and non-Chinese individuals with functional constipation

The diagnosis of functional constipation (FC) relies on patient-reported outcomes evaluated as criteria based on the clustering of symptoms. Although the ROME IV criteria for FC diagnosis is relevant for a multicultural population(1), how an individual’s lifestyle, environment and culture may influence the pathophysiology of FC remains a gap in our knowledge. Building on insights into mechanisms underpinning disorders of gut-brain interactions (formerly functional gastrointestinal disorders) in the COMFORT Cohort(2), this study aimed to investigate the differences in gastrointestinal (GI) symptom scores among participants with FC in comparison to healthy controls between Chinese and non-Chinese New Zealanders. The Gastrointestinal Understanding of Functional Constipation In an Urban Chinese and Urban non-Chinese New Zealander Cohort (GUTFIT) study was a longitudinal cohort study, which aimed to determine a comprehensive profile of characteristics and biological markers of FC between Chinese and non-Chinese New Zealanders. Chinese (classified according to maternal and paternal ethnicity) or non-Chinese (mixed ethnicities) adults living in Auckland classified as with or without FC based on ROME IV were enrolled. Monthly assessment (for 3 months) of GI symptoms, anthropometry, quality of life, diet, and biological samples were assessed monthly over March to June 2023. Demographics were obtained through a self-reported questionnaires and GI symptoms were assessed using the Gastrointestinal Symptom Rating Scale (GSRS) and Structured Assessment of Gastrointestinal Symptoms Scale (SAGIS). This analysis is a cross-sectional assessment of patient-reported outcomes of GI symptoms. Of 78 enrolled participants, 66 completed the study (male, n = 10; female, n = 56) and were distributed across: Chinese with FC (Ch-FC; n = 11), Chinese control (Ch-CON; n = 19), non-Chinese with FC (NCh-FC; n = 16), non-Chinese control (NCh-CON; n = 20). Mean (SD) age, body mass index, and waist circumference were 40 ± 9 years, 22.7 ± 2.5 kg/m2, and 78.0 ± 7.6 cm, respectively. Ethnicity did not impact SAGIS domain scores for GI symptoms (Ethnicity x FC severity interaction p&gt;0.05). Yet, the constipation symptoms domain of the GSRS was scored differently depending on ethnicity and FC status (Ethnicity x FC interaction p&lt;0.05). In post hoc comparison, NCh-FC tended to have higher GSRS constipation severity scores than Ch-FC (3.4 ± 1.0 versus 3.8 ± 0.8 /8, p&lt;0.1) Although constipation symptom severity tended to be higher in NCh-FC, on the whole, ethnicity did not explain variation in this cohort. FC status was a more important predictor of GI symptoms scores. Future research will assess differences in symptom burden to explore ethnicity-specific characteristics of FC.

A Study on Footballers: Is the Mediterranean diet a Good Defender of the Gastrointestinal System?

In football, diet has a highly important role in the development of performance. Assessing the nutrition-related knowledge of footballers and increasing their awareness may affect their health and performance. In this study, which was carried out for this purpose, whether the Mediterranean diet had an effect on the gastrointestinal health of professional footballers was investigated. The sample of the study included a total of 196 active licensed male footballers who were professional players in the 2nd and 3rd football leagues of Turkey. The mean age of the participants was 23.46±4.18 and their mean experience in licensed football was 11.73±5.07 years. The adherence of the participants to the Mediterranean diet was assessed using the Mediterranean Diet Adherence Screener, while the frequencies of gastrointestinal symptoms were examined using the Gastrointestinal Symptom Rating Scale. The data were transferred to the SPSS 26.0 program and analyzed using Pearson’s Correlation Analysis, Independent-Samples T-Tests, One-Way ANOVA and descriptive statistics. According to the results of the analyses, no significant relationship was found between adherence to the Mediterranean diet and gastrointestinal symptoms (p&gt;0.05). While the gastrointestinal symptom scores of the participants did not vary significantly based on their league tiers or positions (p&gt;0.05), their Mediterranean diet adherence scores varied significantly based on their league tiers (p&lt;0.05). Consequently, it was determined that the adherence of the participants to the Mediterranean diet increased as their league tier increased, but adherence to the Mediterranean diet did not create any positive or negative effect on their gastrointestinal system symptoms.

Interventions for Managing Late Gastrointestinal Symptoms Following Pelvic Radiotherapy: a Systematic Review and Meta-analysis

AimsPelvic radiotherapy can induce gastrointestinal injury and symptoms, which can affect quality of life. We assessed interventions for managing these symptoms. Materials and methodsA review of randomised controlled trials published between January 1990 and June 2023 from databases including MEDLINE, EMBASE, CENTRAL, CINAHL, clinicaltrials.gov, ISRCTN and grey literature sources was conducted. Meta-analyses were carried out using the DerSimonian and Laird random effects model to produce overall treatment differences with 95% confidence intervals. ResultsTwenty-eight studies (2392 participants) of varying methodological quality were included. 4% formalin was superior to sucralfate for improving gastrointestinal symptom score (standardised mean difference [SMD] –1.07, 95% confidence interval –1.48 to –0.65). Argon plasma coagulation (APC) was inferior to sucralfate (SMD 1.22, 95% confidence interval 0.84 to 1.59). Counselling positively influenced symptom score (SMD –0.53, 95% confidence interval –0.76 to –0.29), whereas hyperbaric oxygen therapy showed conflicting results. Sucralfate combined with APC increased endoscopic markers of moderate–severe bleeding versus APC alone (risk ratio 2.26, 95% confidence interval 1.12 to 4.55). No definite conclusions on pain, incontinence, diarrhoea, tenesmus or quality of life interventions were confirmed. ConclusionsSmall study sizes, methodological quality and heterogeneity limit support of any individual intervention. APC and 4% formalin seem to be promising interventions, with further larger randomised controlled trials now warranted.

Eating Behavior and Nutritional Profile of Children with Autism Spectrum Disorder in a Reference Center in the Amazon.

There is no single pattern for the evolution of the nutritional status of children with autism spectrum disorder (ASD). Previous studies have found a tendency towards food selectivity with food monotony and difficulties with food texture in children with ASD, but studies in this area, especially in Brazil, are still scarce. The nutritional profile and changes in eating behavior were analyzed in patients with autism spectrum disorder assisted at a reference center in Belém. Eating behavior was assessed using the Labyrinth Scale, nutritional status assessment through weight and height (to calculate body mass index-BMI), and consumption food through the 24 h reminder. A total of 80 children of both sexes participated in the study, the majority of whom were male (80%), 47.5% eutrophic, while for the food consumption of the children evaluated, there was an average energy consumption of 1911 kcal daily, with 57.3%, 15.4%, and 27.3% of carbohydrates, proteins, and lipids, respectively. In relation to eating behavior, the highest averages were demonstrated in the domains of food selectivity, behavioral aspects, and mealtime skills. Masticatory motor scores showed a positive correlation with weight, BMI, and the amount of energy consumed by the child. The gastrointestinal symptoms score showed a negative correlation with the child's age. Regarding mealtime skills, a negative correlation was observed with the proportion of carbohydrates in the diet and a positive correlation with the proportion of lipids consumed in the children's diet. Therefore, knowing the main changes in eating behavior is important to ensure a complete and safe approach for each patient.

Role of cognitive impairment and malnutrition as determinants of quality of life in patients with systemic sclerosis.

Increasing evidence supports the presence of cognitive impairment in patients with systemic sclerosis. Malnutrition is a well-known severe complication of systemic sclerosis and is a consequence of multiple factors, mainly oropharyngeal and gastrointestinal involvement. Recent studies have shown a link between nutrition and cognitive decline in several chronic diseases. Thus, we decided to evaluate a possible association between malnutrition and cognitive impairment in patients with systemic sclerosis. In total, 100 consecutive systemic sclerosis patients were enrolled in a cross-sectional study to assess clinical and demographic features, nutritional status (body mass index, Global Leadership Initiative on Malnutrition criteria), gastrointestinal involvement (University of California Los Angeles Gastrointestinal Scale 2.0, Eat Assessment Tool 10), cognitive function (Montreal Cognitive Assessment), anxiety and depression (Patient Health Questionnaire 9, Beck Depression Inventory II), and quality of life (Short Form 36, Health Assessment Questionnaire-Disability Index, Scleroderma Health Assessment Questionnaire). Patients were stratified for the presence/absence of malnutrition and cognitive decline and compared for clinical characteristics and quality-of-life measures. Half of the patients had cognitive impairment (Montreal Cognitive Assessment < 26). These patients were older, had more comorbidities, and a significantly worse quality of life. There were no statistically significant associations with body mass index, malnutrition, and gastrointestinal involvement. About one-third of patients had clinically relevant malnutrition. They were older, had higher skin score, lung and esophageal involvement. They also showed significantly worse scores for dysphagia, gastrointestinal symptoms, functional disability, and quality of life. Gastrointestinal symptoms and dysphagia, but not body mass index and Montreal Cognitive Assessment, were significantly associated with depression scores, which in turn were negatively associated to quality-of-life measures. With regression analysis, cognitive impairment was predicted only by age, whereas malnutrition was significantly associated with age, dysphagia, and modified Rodnan skin scores. In this study, we showed that cognitive impairment and malnutrition are not directly linked but are both independently associated with greater functional disability and worse quality of life of patients with systemic sclerosis. Early recognition of these comorbidities is therefore pivotal to better address the chronic needs of patients affected by this disease.

Uncovering a Severe Patient Group With Pollen-Related Extrarespiratory Allergic Symptoms: A Year-Long Diary Survey in Japan

BackgroundThe most common symptoms of pollen allergy are rhinitis and conjunctivitis. However, in real-world clinical practice, we sometimes encounter patients with pollen allergy suffering from severe extrarespiratory symptoms including skin, gastrointestinal, or flu-like symptoms in relation to exposure to sensitized pollen. ObjectiveThe aim of this study was to elucidate the extrarespiratory symptoms in patients with pollen allergy MethodsWe performed a non-drug-focused, prospective study of patients with pollen allergy (n=384). During the 1-year observational period, they were asked to complete a weekly e-diary consisting of visual analogue scale (VAS) scores to assess all symptoms experienced in various organs over the past week. An association between seasonal pollen levels and seasonal increase in VAS scores was evaluated using a mixed-effect model for repeated measures. A k-means cluster analysis was performed to identify a group of patients experiencing stronger extrarespiratory symptoms. ResultsIn patients sensitized to grass or birch pollen, higher seasonal levels of these pollen grains were associated with higher VAS scores for headache, gastrointestinal symptoms, skin symptoms, and fatigue. A cluster analysis identified a group of severe pollen-allergic patients with higher extrarespiratory symptoms (n=42). This group was characterized by a higher frequency of comorbid food allergy/atopic dermatitis, higher rate of IgE-sensitization to pollens, and higher impaired activity and work productivity. ConclusionThis 1-year survey identified a small but non-negligible group of patients with pollen-related extrarespiratory symptoms. More attention should be paid to this patient group considering their impaired activity and work productivity.

Efficacy and safety of rifaximin in patients with chronic intestinal pseudo-obstruction: a randomized, double-blind, placebo-controlled, phase II-a exploratory trial.

Chronic intestinal pseudo-obstruction (CIPO) is a rare intractable disease with limited treatment options. Small intestinal bacterial overgrowth (SIBO) often co-occurs with several diseases, including CIPO. While rifaximin (RFX) is effective in treating SIBO, its efficacy for CIPO remains unclear. Here, we aimed to investigate the efficacy and safety of RFX in adult patients with CIPO. Twelve patients were randomly assigned to receive RFX (400 mg three times daily, n=8) or a placebo (PBO, n=4) for 4 weeks. The global symptom score for abdominal bloating (GSS-bloating) and an original whole gastrointestinal symptoms score (O-WGSS) were collected, and a glucose hydrogen breath test (GHBT) and abdominal computed tomography (CT) were performed. No significant differences were observed in the primary endpoint. GSS-bloating improved by 75% and 25% in the PBO and RFX groups, respectively, and O-WGSS improved by 25% in both groups. No significant differences were observed in secondary and other endpoints, including the SIBO eradication rate in the GHBT and small intestinal volume on CT. In a post hoc analysis of SIBO-positive patients with CIPO (4/4 and 4/8 in the PBO and RFX groups), SIBO was eradicated in 25% and 75% of the patients (PBO and RFX groups, respectively) at the end of treatment, indicating a high eradication rate in the RFX group. Furthermore, the small intestinal gas volume decreased in the RFX group, and no severe adverse events occurred. Although no significant improvements were observed in subjective indicators, RFX may be beneficial in alleviating SIBO and reducing the small intestinal gas volume in SIBO-positive patients with CIPO.

A cross-sectional study on stool- and gastrointestinal-related outcomes of Mexican infants consuming different formulae

BackgroundImmaturities present at birth, such as in the gut microbiome and digestive, nervous, and immune system, resolve with time. Nevertheless, this may result in mild digestive symptoms early in life, particularly in formula-fed infants. Formula composition and processing may impact this discomfort. This study therefore aimed to assess stool characteristics and gastrointestinal symptoms of healthy infants fed different formulae.MethodsA multicenter, cross-sectional, observational trial was performed in Mexico between November 2019 and January 2022, where exclusively formula-fed infants (n = 342, aged 1–4 months) were studied in four groups based on their existing formula use. Feeding was continued per practice following label instructions. For 7 days, parents/caregivers were requested to record fecal characteristics, using the Amsterdam Infant Stool Scale, and rate gastrointestinal symptoms. Stool samples were collected to determine pH, dry matter content, and fecal calprotectin levels.ResultsMost infants had a soft/formed stool consistency, although odds for hard stools were different between groups. Gastrointestinal symptom scores revealed significant differences for burping and diarrhea, while other symptoms did not differ between groups. No significant differences between groups were found for stool frequency, dry matter content, and fecal pH. Although calprotectin was within the expected healthy ranges, significant differences among groups were seen. Furthermore, calprotectin significantly correlated with the severity of the gastrointestinal symptoms burping, flatulence, abdominal distension, and diarrhea.ConclusionsDifferences in stool characteristics and specific differences in gastrointestinal symptoms were observed between different formula brand users. This may potentially be explained by the different composition and processing of the formulae, although there are multiple factors that influence the assessed outcomes.Trial registrationThe study was registered in the Netherlands Trial Registry (NL7805), linked to https://trialsearch.who.int/, on 11/06/2019.

The effect of expectancy versus actual gluten intake on gastrointestinal and extra-intestinal symptoms in non-coeliac gluten sensitivity: a randomised, double-blind, placebo-controlled, international, multicentre study

Many individuals without coeliac disease or wheat allergy reduce their gluten intake because they believe that gluten causes their gastrointestinal symptoms. Symptoms could be affected by negative expectancy. Therefore, we aimed to investigate the effects of expectancy versus actual gluten intake on symptoms in people with non-coeliac gluten sensitivity (NCGS). This randomised, double-blind, placebo-controlled, international, multicentre study was done at the University of Leeds (Leeds, UK), Maastricht University (Maastricht, the Netherlands), and Wageningen University and Research (Wageningen, the Netherlands). People aged 18-70 years with self-reported NCGS (ie, gastrointestinal symptoms within 8 h of gluten consumption) without coeliac disease and wheat allergy were recruited. Participants had to follow a gluten-free or gluten-restricted diet for at least 1 week before (and throughout) study participation and had to be asymptomatic or mildly symptomatic (overall gastrointestinal symptom score ≤30 mm on the Visual Analogue Scale [VAS]) while on the diet. Participants were randomly assigned (1:1:1:1; blocks of eight; stratified by site and gender) to one of four groups based on the expectation to consume gluten-containing (E+) or gluten-free (E-) oat bread for breakfast and lunch (two slices each) and actual intake of gluten-containing (G+) or gluten-free (G-) oat bread. Participants, investigators, and those assessing outcomes were masked to the actual gluten assignment, and participants were also masked to the expectancy part of the study. The primary outcome was overall gastrointestinal symptom score on the VAS, which was measured at and corrected for baseline (before breakfast) and hourly for 8 h, with lunch served after 4 h, and analysed per-protocol. Safety analysis included all participants incorporated in the per-protocol analysis. The study is registered at ClinicalTrials.gov, NCT05779358, and has ended. Between Oct 19, 2018, and Feb 14, 2022, 165 people were screened and 84 were randomly assigned to E+G+ (n=21), E+G- (n=21), E-G+ (n=20), or E-G- (n=22). One person in the E+G+ group was excluded due to not following test day instructions, leaving 83 participants in the per-protocol analysis. Median age was 27·0 years (IQR 21·0-45·0), 71 (86%) of 83 people were women, and 12 (14%) were men. Mean overall gastrointestinal symptom score was significantly higher for E+G+ (16·6 mm [95% CI 13·1 to 20·0]) than for E-G+ (6·9 mm [3·5 to 10·4]; difference 9·6 mm [95% CI 3·0 to 16·2], p=0·0010) and E-G- (7·4 mm [4·2 to 10·7]; difference 9·1 mm [2·7 to 15·6], p=0·0016), but not for E+G- (11·7 mm [8·3 to 15·1]; difference 4·9 mm [-1·7 to 11·5], p=0·28). There was no difference between E+G- and E-G+ (difference 4·7 mm [-1·8 to 11·3], p=0·33), E+G- and E-G- (difference 4·2 mm [-2·2 to 10·7], p=0·47), and E-G+ and E-G- (difference -0·5 mm [-7·0 to 5·9], p=1·0). Adverse events were reported by two participants in the E+G- group (itching jaw [n=1]; feeling lightheaded and stomach rumbling [n=1]) and one participant in the E-G+ group (vomiting). The combination of expectancy and actual gluten intake had the largest effect on gastrointestinal symptoms, reflecting a nocebo effect, although an additional effect of gluten cannot be ruled out. Our results necessitate further research into the possible involvement of the gut-brain interaction in NCGS. Government of the Netherlands Topsector Agri & Food Top Consortium for Knowledge and Innovation, AB Mauri Global Bakery Ingredients, Baking Industry Research Trust, Borgesius-Albert Heijn, CSM Innovation Centre, the International Maize and Wheat Improvement Center (CIMMYT), DSM Food Specialties, Fazer, Healthgrain Forum, the International Association for Cereal Science and Technology, the International Wheat Gluten Association, Lantmännen, Mondelez International, Nederlands Bakkerij Centrum, Nutrition & Santé, Puratos, Rademaker, Sonneveld Group, and Zeelandia HJ Doeleman.

Gastrointestinal Tolerability and Acute Glycemic Response of Oligosaccharides and Polysaccharides from Cellulose and Xylan in Healthy Adults: Two Double-Blinded, Randomized, Controlled, Cross-over Trials

Objective The aim of this study was to investigate the gastrointestinal tolerability, glycemic and insulinemic responses of Plant Fiber Extract (PFE), a mixture comprising of oligosaccharides and polysaccharides derived from cellulose and xylan. Methods Two double-blind, randomized, controlled, cross-over trials were conducted in healthy adults. In the first trial, participants (n = 29) consumed either 25, 35 or 45 g per day of PFE or resistant maltodextrin (Control) for 14 days. The occurrence and severity of gastrointestinal (GI) symptoms, stool parameters, and safety outcomes were evaluated with a combination of surveys and blood analysis respectively. In the second trial (n = 20), the post-prandial glycemic and insulinemic responses after the ingestion of 20 g of PFE diluted in water or incorporated into chocolate chips was measured and then compared to that of glucose and regular chocolate, respectively. Results For all timepoints (0, 7 and 14 days), within any given dose group, there was no statistically significant difference in the GI symptoms score between PFE and Control. Further, for each test product (PFE or Control), no difference was observed in the same dose group from days 0 and 14. Stool consistency score and number of participants experiencing loose or watery stools was similar between products. No serious adverse events were reported and neither PFE nor Control significantly altered blood or urine safety parameters. The glycemic and insulinemic responses after PFE ingestion in comparison to glucose were 12% and 8% respectively. The glycemic and insulinemic responses after consuming chocolate containing PFE were 20% of that of regular chocolate. Conclusion PFE was well-tolerated by healthy volunteers in doses up to 45 g/day and it elicited comparatively low glycemic and insulinemic responses when consumed alone or when incorporated into a food product.