Efficacy and safety of Gelsectan for diarrhoea-predominant irritable bowel syndrome: A randomised, crossover clinical trial. Issue 8 (October 2019)

• Record Type: Journal Article
• Authors: Trifan, Anca; Burta, Ovidiu; Tiuca, Nicoleta; Petrisor, Diana Corina; Lenghel, Augustin; Santos, Javier
• Is Part Of: United European Gastroenterology journal. Volume 7:Issue 8(2019)
• Page Start: 1093
• Page End: 1101
• Publication Date: 2019-10
• Subjects: Diarrhoea-predominant irritable bowel syndrome -- Gelsectan -- pea protein and tannins -- prebiotics -- mucoprotectants -- xyloglucan -- xylo-oligosaccharide; Gastroenterology -- Periodicals; Periodicals; 616.33005
• DOI: 10.1177/2050640619862721
• Languages: English
• ISSNs: 2050-6406

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.