Study of Gelsectan for Treating Diarrhea-Predominant Irritable Bowel Syndrome in Adults Aged 18 to 65

What this Trial Is About

Irritable Bowel Syndrome with diarrhea IBS-D is a common gut-brain interaction disorder that significantly affects quality of life, mental health, and work productivity. Current treatments often provide only partial relief, and many patients remain dissatisfied. This research aims to evaluate the safety and effectiveness of Gelsectan, a medical device designed to protect and restore the intestinal mucosal barrier, compared with a placebo in adults with IBS-D. Participants will receive either Gelsectan or a placebo capsule twice daily for 8 weeks. The dosing schedule starts with two capsules in the morning and evening during the first 4 weeks, followed by one capsule twice daily for the next 4 weeks. Gelsectan contains film-forming compounds such as Xyloglucan, Pea protein, grape seed extract, and Xylo-Oligosaccharides, which may help relieve symptoms like diarrhea, abdominal pain, bloating, and flatulence. Throughout the study, patients will complete electronic diaries recording abdominal pain and stool consistency, with assessments every 4 weeks and at the end of the 8-week treatment. The study will also monitor overall IBS symptom severity, quality of life, depression symptoms, work productivity, use of rescue therapy, and safety measures including vital signs and laboratory tests. The total study duration includes an 8-week treatment period plus a 4-week post-treatment follow-up.

Gelsectan® in the Treatment of Patients With Diarrhoea-predominant Irritable Bowel Syndrome