Literature DB >> 31662866

Efficacy and safety of Gelsectan for diarrhoea-predominant irritable bowel syndrome: A randomised, crossover clinical trial.

Anca Trifan1, Ovidiu Burta2, Nicoleta Tiuca3, Diana Corina Petrisor4, Augustin Lenghel5, Javier Santos6.   

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. © Author(s) 2019.

Entities:  

Keywords:  Diarrhoea-predominant irritable bowel syndrome; Gelsectan; mucoprotectants; pea protein and tannins; prebiotics; xylo-oligosaccharide; xyloglucan

Mesh：

Substances：

Year:  2019        PMID： 31662866      PMCID： PMC6794699          DOI： 10.1177/2050640619862721

Source DB:  PubMed          Journal:  United European Gastroenterol J        ISSN： 2050-6406            Impact factor:   4.623


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