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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.

Gastroparesis is a motility disorder that causes severe gastric symptoms and delayed gastric emptying, where the majority of sufferers are females (80%), with 29% of sufferers also diagnosed with Type-1 or Type-2 diabetes. Current clinical recommendations involve stringent dietary restriction and includes the avoidance and minimization of dietary fibre. Dietary fibre lowers the glycaemic index of food, reduces inflammation and provides laxation. Lack of dietary fibre in the diet can affect long-term gastrointestinal health. Our previously published rheological study demonstrated that “low-viscosity” soluble fibres could be a potentially tolerable source of fibre for the gastroparetic population. A randomised controlled crossover pilot clinical study was designed to compare Partially-hydrolysed guar gum or PHGG (test fibre 1), gum Arabic (test fibre 2), psyllium husk (positive control) and water (negative control) in mild-to-moderate symptomatic gastroparesis patients (requiring no enteral tube feeding). The principal aim of the study was to determine the short-term physiological effects and tolerability of the test fibres. In n = 10 female participants, post-prandial blood glucose, gastroparesis symptoms, and breath test measurements were recorded. Normalized clinical data revealed that test fibres PHGG and gum Arabic were able to regulate blood glucose comparable to psyllium husk, while causing far fewer symptoms, equivalent to negative control. The test fibres did not greatly delay mouth-to-caecum transit, though more data is needed. The study data looks promising, and a longer-term study investigating these test fibres is being planned.

Psyllium is a widely used treatment for constipation. It traps water in the intestine increasing stool water, easing defaecation and altering the colonic environment. We aimed to assess the impact of psyllium on faecal microbiota, whose key role in gut physiology is being increasingly recognised. We performed two randomised, placebo-controlled, double-blinded trials comparing 7 days of psyllium with a placebo (maltodextrin) in 8 healthy volunteers and 16 constipated patients respectively. We measured the patients’ gastrointestnal (GI) transit, faecal water content, short-chain fatty acid (SCFA) and the stool microbiota composition. While psyllium supplement had a small but significant effect on the microbial composition of healthy adults (increasing Veillonella and decreasing Subdoligranulum), in constipated subjects there were greater effects on the microbial composition (increased Lachnospira, Faecalibacterium, Phascolarctobacterium, Veillonella and Sutterella and decreased uncultured Coriobacteria and Christensenella) and alterations in the levels of acetate and propionate. We found several taxa to be associated with altered GI transit, SCFAs and faecal water content in these patients. Significant increases in three genera known to produce butyrate, Lachnospira, Roseburia and Faecalibacterium, correlated with increased faecal water. In summary, psyllium supplementation increased stool water and this was associated with significant changes in microbiota, most marked in constipated patients.

•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.

•Many adults do not consume the recommended 25 to 30 g of dietary fiber per day.•Clinical trials have shown that 10 to 21 g of psyllium daily improves blood lipids.•Clinical trials have demonstrated that 6 to 8 g of oat bran β-glucan daily improves blood lipids.•Clinical trials have found that 10 to 15 g of PolyGlycopleX daily improves blood lipids.•Effects of these fibers on weight, hypertension, and blood glucose need clarification. The persistent obesity crisis, with its increased risk for the metabolic syndrome (MetS), type 2 diabetes, and cardiovascular disease (CVD), continues to damage the health of populations globally, including children. Diets rich in the fiber provided by fruit and vegetables support good metabolic health, although few adults and children achieve the recommended daily target. Daily fiber supplementation, particularly with soluble fiber products, such as psyllium, oat bran, or a newer product such as PolyGlycopleX, may provide a convenient solution. Literature searches were conducted to identify original research articles, systematic reviews, and meta-analyses with the search terms psyllium, oat bran, PolyGlycopleX, and PGX, AND adults and children AND overweight, obesity, and metabolic syndrome. Data source was Embase and PubMed from 1980 to 2017. The results show that the addition of a soluble fiber product, most notably psyllium, improves blood lipid profiles, particularly total and low-density lipoprotein cholesterol, as well as glycemic response, and increases satiety, and by thus improving MetS and CVD risk factors, may augment the processes initiated by weight reduction diets. Although less studied than psyllium, the available evidence has shown that β-glucan present in oat bran has a beneficial effect on MetS and CVD risk factors, particularly blood lipids and glycemia. Early research has found PolyGlycopleX to provide similar benefits to other soluble fiber products, and suggest it may also assist with weight loss. This critical review demonstrates that soluble fiber supplements used as an adjunct to dietary and lifestyle modifications may assist with the treatment of CVD and MetS risk factors. More research is needed to further clarify the benefits of PolyGlycopleX in particular, as well as to develop safe and efficacious recommendations for fiber supplementation of all types for children in general.

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.

Assesses the effects of psyllium supplementation on insulin sensitivity and other parameters of the metabolic syndrome in an at risk adolescent population of 47 healthy adolescent males aged 15–16 years, recruited from secondary schools in lower socio-economic areas of Auckland with high rates of obesity. Source: National Library of New Zealand Te Puna Matauranga o Aotearoa, licensed by the Department of Internal Affairs for re-use under the Creative Commons Attribution 3.0 New Zealand Licence.

This work presents a method to encapsulate plant extracts within a binary polysaccharide carrier and to characterize the physicochemical and rheological performance of the resulting biocomposites in the context of food use. Using a starch/psyllium matrix, extracts from Sambucus nigra (SN), Aronia melanocarpa (AM), and Echinacea purpurea (EP) were effectively protected and incorporated through a stepwise workflow encompassing matrix preparation, encapsulation, structural verification, and functional assessment. SEM revealed a porous network containing uniformly distributed, extract-loaded spherical structures (~800–1500 nm), while FTIR supported the presence of hydrogen bonding and hydrophobic interactions that contributed to system stability. The prepared nanoemulsions showed shear-thinning (pseudoplastic) behavior, indicating favorable processing characteristics, whereas most physicochemical and bioactivity measurements were performed on lyophilized composites. The dried materials preserved extract-specific color signatures (ΔE > 5) and exhibited distinct thermal responses: AM produced a pronounced plasticizing effect (Tg reduced by >20 °C), while the incorporation of extracts generally delayed thermal degradation, consistent with polyphenol–starch interactions. Phase-transition behavior was also altered, with melting peaks suppressed for SN and AM and melting temperatures lowered for EP. Surface analysis indicated increased hydrophobicity and a reduced polar component of surface free energy, suggesting improved moisture barrier potential. Antioxidant capacity closely tracked total phenolic content (r > 0.94), with caffeic acid contributing strongly, particularly in EP-based systems. Antimicrobial activity depended on extract type (broad-spectrum for EP, selective for SN, minimal for AM), and the comparatively higher sensitivity of Gram-negative bacteria points to improved phenolic availability and membrane interactions upon encapsulation. Collectively, these results highlight the starch/psyllium matrix as a flexible platform for stabilizing plant extracts while enabling tunable functional attributes for functional food applications.

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.

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.