Open AccessEfficacy and safety of Gelsectan for diarrhoea‐predominant irritable bowel syndrome: A randomised, crossover clinical trial
Author(s) -
Trifan Anca,
Burta Ovidiu,
Tiuca Nicoleta,
Petrisor Diana Corina,
Lenghel Augustin,
Santos Javier
Publication year - 2019
Publication title -
ueg journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.667
H-Index - 35
eISSN - 2050-6414
pISSN - 2050-6406
DOI - 10.1177/2050640619862721
Subject(s) - medicine , placebo , bloating , irritable bowel syndrome , adverse effect , abdominal pain , crossover study , gastroenterology , quality of life (healthcare) , clinical trial , randomized controlled trial , alternative medicine , nursing , pathology
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.