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Background Fecal incontinence (FI) is a prevalent condition affecting 2% to 21% of the general population, with higher rates in older adults and specific settings such as nursing homes and hospitals. Current treatments include supportive care, biofeedback, anal injections, and sacral nerve stimulation, though these can be invasive or costly. Pharmacological therapies, like stool bulking agents and constipating agents, help manage symptoms but can have side effects. Ramosetron, a 5-HT3 receptor antagonist, shows promise for FI treatment by reducing intestinal motility and improving stool consistency. This study aims to compare the effectiveness and safety of ramosetron (Irribow ® ) and psyllium (AGIO ® ) in treating FI in a randomized, parallel, non-inferiority trial. Methods This study will include adults aged 19 years and above who are diagnosed with FI. Participants will be randomly assigned to receive either ramosetron (5 μg for males, 2.5 μg for females) or psyllium (6 g) once daily. The primary endpoint will compare changes in Fecal Incontinence Severity Index (FISI) scores before and after medication. Secondary endpoints will include comparisons of FISI scores, Fecal Incontinence Quality of Life (FIQL) scores, patient satisfaction surveys, and Bristol Stool Scale scores between the two groups. Follow-up visits will take place at baseline and at 1, 4, and 12 months to assess symptoms and administer surveys. The primary endpoint is the within-group improvement in FISI scores, while the secondary endpoint is a between-group non-inferiority comparison of ramosetron versus psyllium. A sample size of 56 participants is needed for statistical significance at the 0.05 level with 80% power, accounting for dropout, for a total of 148 participants. Discussion It is believed that 5-HT3 receptor antagonists, along with Psyllium, can improve bowel habits and alleviate symptoms, thereby enhancing the quality of life for patients with FI. Trial registration ClinicalTrials.gov NCT06166615, December 12, 2023.

•Although previous studies have evaluated the health benefits of psyllium in patients with T2D and indicate that it may be improve bowel movement (Singh, 2007, Ramkumar and Rao, 2005, Brandt et al., 2005), glycemic and lipid control (Gibb et al., 2015, Ziai et al., 2005, Rodriguez-Moran et al., 1998, Cicero et al., 2010, Feinglos et al., 2013, Aller et al., 2004, Dall’Alba et al., 2013, Steemburgo et al., 2009, Wolfram and Ismail-Beigi, 2010), and body weight (Frati-Munari et al., 1982), no data are available for constipated patients with T2D.•In constipated patients with T2D, psyllium cookies used as a snack may be a useful tool for decreasing constipation symptoms, weight, glycemic, and lipid levels.•More studies are warranted to confirm our observations. To compare the effects of baked psyllium supplementation versus those who received a placebo on constipation symptoms, body weight, glycemic and lipids control in patients with type 2 diabetes (T2D) and chronic constipation. In a single-blinded, randomized controlled trial, 51 patients with T2D and chronic constipation with body mass index (BMI) 20–47 kg/m2 received either 10 g of psyllium pre-mixed in cookies twice per day or placebo cookies for 12 weeks. Constipation symptoms, body mass index (BMI), fasting plasma glucose (FPG), glycosylated hemoglobin (HbA1c), and lipid profile were determined at the beginning and end of 4, 8, and 12-week period. Constipation was evaluated with a stool diary (ROME III). The psyllium group showed improvement in constipation symptoms, body weight, glucose and lipid values compared with the baseline and the placebo group. Body weight and FPG decreased from baseline in the psyllium group (P < 0.001 and P = 0.056, respectively). The differences (95% CI) of absolute change of body weight (−2.0 (−3.0, −1.0) kg; P < 0.001), FPG (−13.6 (−24.3, −2.9) mg/dl; P = .040), and HbA1c (−1.7 (−2.9, −0.5)); P = 0.002) between the groups were statistically significant. Cholesterol (−21.5 (−25.6, −14.4); P < 0.001), triglycerides (−20.0 (−32.3, −7.7); P = 0.021) and constipation symptoms (1.5 (0.4, 2.3); P < 0.001) decreased in the psyllium group. The compliance was good and no adverse effects were observed. In patients with T2D and chronic constipation, psyllium supplementation decreased constipation symptoms, body weight, glycemic, cholesterol, and increased HDLC levels.

Optimum levels and types of dietary fibre that provide the greatest beneficial effects on metabolic syndrome risk factors in overweight and obese individuals have yet to be determined in clinical trials. The present parallel design study compared the effects of fibre intake from a healthy diet v. a fibre supplement (psyllium) or a healthy diet plus fibre supplement on fasting lipids, glucose, insulin and body composition. Overweight/obese adults were randomised to either control (with placebo), fibre supplement (FIB), healthy eating plus placebo (HLT) or healthy eating plus fibre supplement (HLT–FIB). There was a significant increase in fibre intake in HLT–FIB, HLT and FIB groups up to 59, 31 and 55 g, respectively, at 12 weeks when compared to control (20 g). Weight, BMI and % total body fat were significantly reduced in FIB and HLT–FIB groups, with weight and BMI significantly reduced in the HLT group compared with control at 12 weeks. HLT–FIB and HLT groups had significant reductions in TAG and insulin compared with control at 6 and 12 weeks, and in insulin compared with the FIB group at 12 weeks. The HLT–FIB, HLT and FIB groups all had significant reductions in total cholesterol and LDL-cholesterol compared with control after 6 and 12 weeks. The present study demonstrated that simply adding psyllium fibre supplementation to a normal diet was sufficient to obtain beneficial effects in risk factors. However, a high-fibre diet consisting of a psyllium supplement plus fibre from a healthy diet provided the greatest improvements in metabolic syndrome risk factors.

Studies suggest that synbiotic therapy could prove more effective in the treatment of ulcerative colitis (UC) than therapies limited to probiotics or prebiotics. This study compared the effect of each of these therapies in the treatment of UC. One hundred twenty outpatients with UC were randomly sorted into three groups of 40 patients each for probiotic, prebiotic, or synbiotic therapy. The probiotic group ingested one daily capsule consisting of Bifidobacterium longum 2 × 10 9 colony-forming units and the prebiotic group ingested daily 8.0-g doses of psyllium. The synbiotic group underwent both treatments. All patients completed Inflammatory Bowel Disease Questionnaires (IBDQs) at the onset of the trial, at the 2-wk midpoint, and at the 4-wk end of the trial. Blood variables were also evaluated in a subset of 32 patients randomly selected from all groups and values were compared with IBDQ scores. Thirty-one patients in the probiotic group, 31 in the prebiotic group, and 32 in the synbiotic group qualified for analyses. The remaining 26 patients had incomplete questionnaires. Total IBDQ scores improved within groups by the end of the trial (probiotics 162 to 169, NS; prebiotics 174 to 182, NS; synbiotics 168 to 176, P = 0.03). Individual scores improved as follows: probiotics, emotional function ( P = 0.03); prebiotics, bowel function ( P = 0.04); and synbiotics, systemic and social functions ( P = 0.008 and P = 0.02). C-reactive protein decreased significantly only with synbiotic therapy (from 0.59 to 0.14 mg/dL, P = 0.04). There were no adverse events. Patients with UC on synbiotic therapy experienced greater quality-of-life changes than patients on probiotic or prebiotic treatment. These data suggest that synbiotic therapy may have a synergistic effect in the treatment of UC.

Psyllium and lactitol have been reported to increase fecal volume, moisture content and bowel movement frequency (BMF). However, the benefits of their combined use on constipation has not been examined. The aim of this study was to evaluate the effects of a 4-week intervention with lactitol and/or psyllium on bowel function in constipated volunteers. Adults (N = 172) who were diagnosed with functional constipation per Rome III criteria were randomized to four treatment groups: 10 g lactitol, 3.5 g psyllium, a combination of 10 g lactitol and 3.5 g psyllium, or placebo. The primary endpoint was change in BMF from Day 0 to 28 as compared to placebo. Secondary endpoints were assessed by inventories, including stool consistency, patient assessment of constipation symptoms and quality of life, relief of constipation, 24-h food recall, physical activity, product satisfaction and adverse events (AE). BMF increased by 3.0 BMs with lactitol, by 2.9 with psyllium, and by 3.1 with the combination, but was not different from placebo (3.7 BMs). Other clinical endpoints were similar between treatments. No serious AEs were reported. In conclusion, this study showed a similar effect on relief of constipation in all treatment groups. The treatments that were administered to the volunteers were well tolerated.

The aim of the study was to compare the effectiveness of a low fermentable oligosaccharide, disaccharide, monosaccharide, and polyol diet (LFD) vs psyllium on the frequency and severity of fecal incontinence (FI) episodes in patients with loose stools. This was a single-center, randomized pilot trial of adult patients with FI (Rome III) with at least 1 weekly FI episode associated with loose stool. Eligible patients were randomized to 4 weeks of either a dietitian-led LFD or 6 g/d psyllium treatment. Forty-three subjects were randomized from October 2014 to May 2019. Thirty-seven patients completed the study (19 LFD and 18 psyllium). There was no statistically significant difference in the proportion of treatment responders (>50% reduction in FI episodes compared with baseline) for treatment weeks 1-4 (LFD 38.9%, psyllium 50%, P = .33). Compared with baseline, mean fecal incontinence severity index score significantly improved with LFD (39.4 vs 32.6, P = .02) but not with psyllium (35.4 vs 32.1, P = .29). Compared with baseline values, the LFD group reported improvements in fecal incontinence quality of life coping/behavior, depression/self-perception, and embarrassment subscales. The psyllium group reported improvement in incontinence quality of life coping/behavior. In this pilot study, there was no difference in the proportion of patients who reported a 50% reduction of FI episodes with the LFD or psyllium. Subjects in the psyllium group reported a greater reduction in overall FI episodes, whereas the LFD group reported consistent improvements in FI severity and quality of life. Further work to understand these apparently discrepant results are warranted but the LFD and psyllium seem to provide viable treatment options for patients with FI and loose stools.

Objectives: Evidences from randomized clinical trials and meta-analysis have claimed an association between the use of soluble dietary fiber from psyllium and a cholesterol-lowering effect. However, there is still uncertainty as to the dose-response relationship and its long-term lipid-lowering efficacy. This meta-analysis was primarily conducted to address the dose-response relationship between psyllium and serum cholesterol level and time-dependent effect of psyllium in mild-to-moderate hypercholesterolemic subjects. Methods: Twenty-one studies, which enrolled a total of 1030 and 687 subjects receiving psyllium or placebo, respectively, were included in the meta-analysis. The studies were randomized placebo-controlled trials, double blinded or open label, on subjects with mild-to-moderate hypercholesterolemia. The dose of psyllium was between 3.0 and 20.4 g per day and intervention period was more than 2 weeks. Any type of diet background was permitted. Diet lead-in period was between 0 and 8 weeks. Results: Compared with placebo, consumption of psyllium lowered serum total cholesterol by 0.375 mmol/l (95% CI: 0.257-0.494 mmol/l), and LDL cholesterol by 0.278 mmol/l (95% CI: 0.213-0.312 mmol/l). With random-effect meta-regression, a significant dose-response relationship were found between doses (3-20.4 g/day) and total cholesterol or LDL cholesterol changes. Regression model of total cholesterol was -0.0222+0.2061 log (dose+1), and that of LDL cholesterol was 0.0485+0.1390 log (dose+1). There was a time effect of psyllium on total cholesterol (equation: 6.3640-0.0316 treatment period) and on LDL cholesterol (equation: 4.3134-0.0162 treatment period), suggesting that psyllium reduced serum total cholesterol more quickly than LDL cholesterol. Conclusions: Psyllium could produce dose- and time-dependent serum cholesterol-lowering effect in mild and moderate hypercholesterolemic patients and would be useful as an adjunct to dietary therapy for the treatment of hypercholesterolemia.

Functional gastrointestinal disorders including constipation affect up to 14 % of the world's population. Treatment is difficult and challenging resulting in a need for alternative safe and effective therapies. The present study investigated whether daily consumption of three gold-fleshed kiwifruit could alleviate constipation and improve gastrointestinal discomfort in mildly constipated individuals with and without pain. A total of thirty-two participants were enrolled in a 16-week randomised, single-blind, crossover study. Participants received either three ‘Zesy002’ kiwifruit or 14·75 g Metamucil ® (5 g dietary fibre/d (a positive control)) for 4 weeks each with a 4-week washout between treatments. A 2-week washout period was included at the beginning and end of the study. Daily bowel habit diaries were kept throughout the study. The primary outcome measure was differences in the number of complete spontaneous bowel movements (CSBM). Secondary outcome measures were bowel movement frequency and stool form as well as digestive symptoms and comfort. The number of CSBM per week was significantly greater during daily consumption of three kiwifruit compared with the baseline (6·3 v. 3·3; P < 0·05) and the Metamucil ® treatment (6·3 v. 4·5; P < 0·05). Stool consistency was also improved, with kiwifruit producing softer stools and less straining ( P < 0·05). Gastrointestinal discomfort was also improved compared with baseline for abdominal pain, constipation and indigestion ( P < 0·05) during the kiwifruit intervention and constipation during the Metamucil ® intervention ( P < 0·05). This randomised controlled trial demonstrates that daily consumption of three gold-fleshed kiwifruit is associated with a significant increase of two CSBM per week and reduction in gastrointestinal discomfort in mildly constipated adults.

Endothelial dysfunction and increased arterial stiffness occur early in the pathogenesis of the metabolic syndrome and they are both powerful independent predictors of cardiovascular risk. A high-fibre diet has been correlated with lower BMI and a lower incidence of hyperlipidaemia, CVD, hypertension and diabetes. The present randomised, parallel-design study compared the effects of fibre intake from a healthy diet v. fibre supplement diets on blood pressure (BP) and vascular function over 12 weeks. Overweight and obese adults were randomised to one of three groups: control (with placebo), fibre supplement (FIB) or healthy eating group with placebo (HLT). Systolic blood pressure (SBP) was lower in the FIB group compared with the control group at week 6, but not at week 12. However, SBP was lower in the HLT group compared with control group at week 12. At week 6, the FIB group presented lower diastolic blood pressure and augmentation index compared with the control group, but this result did not persist to the end of the study. The present study did not show any improvements in BP or vascular function in overweight and obese individuals with psyllium fibre supplementation over 12 weeks of intervention. However, a healthy diet provided the greatest improvements in BP in overweight and obese subjects. Further research with hypertensive individuals is necessary to elucidate whether increased fibre consumption in the form of psyllium supplementation may provide a safe and acceptable means to reduce BP, vascular function and the risk of developing CVD.

We examined the effects of 2 months of psyllium treatment in optimizing metabolic control and lipoprotein profile, and its postprandial effects on lipids in type II diabetes. We recruited 40 type II diabetic patients who were on sulfonylureas and a controlled diet, sequentially assigning them to psyllium treatment (G1) or to a control group (G2) treated with dietary measures alone. After 2 months of treatment, body mass index, waist circumference, HbA1c (hemoglobin A1c) and fasting plasma glucose levels had significantly decreased in both groups. There were no postprandial differences in the lipoprotein profile between the two groups. Triglycerides were significantly lower in G1, but not in G2. Our study contributes toward elucidating the effects of psyllium on serum lipids, and suggests that psyllium treatment may help in reducing triglycerides (a known risk factor for cardiovascular disease) in type II diabetic patients.