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

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.

Impact of Diet on Symptoms of the Irritable Bowel Syndrome

“…The same group showed, in a group of post-infectious IBS with impaired barrier function, that glutamine treatment improved both barrier function and symptoms [ 26 ]. A more recent study using a combination of xyloglucan and pea protein and grape tannins supports the idea that enhancing barrier function might be therapeutic in IBS-D patients [ 27 ].…”

The Role of Purported Mucoprotectants in Dealing with Irritable Bowel Syndrome, Functional Diarrhea, and Other Chronic Diarrheal Disorders in Adults

“…Other secondary outcome measures included changes in bowel movement disorders and bloating 8 weeks On day 56, diosmectite reduced VAS score of IBS overall disorder ( P = 0.0167) and abdominal pain ( P < 0.05) as compared to placebo. Both treatments effectively diminished bowel movement frequency, but group differences were not found, while only diosmectite improved abdominal bloating at each visit Xyloglucan Alexea O, 2016 [ 131 ] Spain, Romania A mixture of vegetable oligo- and polysaccharides: 750 mg; reticulated protein: 250 mg; and the excipients corscarmellose sodium: 133 mg; and magnesium stearate:17 mg; or placebo (corn starch, croscarmellose sodium and magnesium stearate) four tablets/day (two before breakfast and two before dinner) for 56 days IBS-D Active group: 48.8 ± 14; Placebo group:47.7 ± 14.2 Multicenter, randomized, placebo-controlled, double-blind, parallel group 63 65 Stool consistency, bowel frequency, abdominal pain, bloating, quality of life and general health 56 days Remission of diarrhea and improvement of abdominal pain, flatulence, bowel frequency and quality of life was shown in those in the active group as compared with placebo Trifan A, 2019 [ 130 ] Romania Xyloglucan + pea protein and tannins + xylo-oligosaccharides/ placebo, 1 capsule b.i.d for 28 days, followed by crossover to the alternate treatment for 28 days IBS-D Active group: 35.0 ± 7.8; Placebo group:34.5. ± 8.1 Multicenter, randomized double-blind, placebo-controlled, crossover 30 30 Stool consistency, abdominal pain, bloating, quality of life and general health 116 days Xyloglucan combination shown to be safe and efficacious to improve stool consistency, abdominal pain, bloating, quality of life and general health.…”

“…However, there are limited data regarding its use in chronic diarrhea. One recent multicenter, double-blind, placebo-controlled, randomized, crossover clinical trial evaluated the efficacy and safety of a commercially available combination of XG, pea protein, and tannins from grape seed extract, and xylo-oligosaccharides in patients with IBS-D [ 130 ]. The study showed that, at day 28, the therapeutic combination of XG normalized stool consistency in a significantly higher proportion of patients as compared to placebo (87 vs. 0%; P = 0.0019), and, after the crossover, at day 56, the effect of XG was reproduced (93% vs. 23%; P = 0.0001).…”

(Poly)phenols in Inflammatory Bowel Disease and Irritable Bowel Syndrome: A Review

“…Gelsectan is a supplement that combines tannins with xyloglucan, pea protein. Gelsectan supplementation was found to increase frequency of stool type 3–4 on the Bristol stool scale; however, the dose of tannins in Gelsectan was not specified, and therefore the results should be interpreted with caution [ 63 ]. Subjects supplemented with ginger reported no difference in adequate relief when opening bowels [ 64 ].…”