Efficacy and safety of Gelsectan for diarrhoea-predominant irritable bowel syndrome: A randomised, crossover clinical trial.
Ontology highlight
ABSTRACT: Background:Irritable bowel syndrome (IBS) is highly prevalent and presents a clinical challenge. Gelsectan is a medical device containing xyloglucan (XG), pea protein and tannins (PPT) from grape seed extract, and xylo-oligosaccharides (XOS), which act together to protect and reinforce the intestinal barrier. Objective:The objective of this study is to evaluate the efficacy and safety of XG?+?PPT?+?XOS in patients with diarrhoea-predominant IBS (IBS-D). Methods:In this double-blind study, 60 patients were randomly assigned to receive XG?+?PPT?+?XOS or placebo for 28 days, then crossed over to the alternative treatment. Patients were followed for 60 days. Results:At Day 28, a significantly higher proportion of patients starting treatment with XG?+?PPT?+?XOS than placebo (87 vs 0%; p?=?0.0019) presented normal stools (Bristol Stool Form Scale type 3-4). At Day 56, a significantly higher proportion of patients who crossed over to XG?+?PPT?+?XOS than placebo (93% vs 23%; p?=?0.0001) presented normal stools. In the group allocated to receive XG?+?PPT?+?XOS after placebo, benefits of XG?+?PPT?+?XOS were maintained during follow-up. Subjective assessments of abdominal pain, bloating, quality of life and general health indicated significant improvement with XG?+?PPT?+?XOS over placebo. There were no related adverse events. Conclusion:XG?+?PPT?+?XOS effectively controlled diarrhoea and alleviated clinical symptoms in patients with IBS-D, and was well tolerated.
SUBMITTER: Trifan A
PROVIDER: S-EPMC6794699 | biostudies-literature | 2019 Oct
REPOSITORIES: biostudies-literature
ACCESS DATA