Efficacy and Safety of Pea Protein and Xyloglucan Versus Simethicone in Functional Abdominal Bloating and Distension.

BACKGROUND: Functional Abdominal Bloating and Distension (FABD) is a multifaceted condition related in part to trapped gas, with changes in the intestinal barrier and small intestinal bacterial overgrowth (SIBO), which lead to gas production. Currently, there are no treatments targeting the etiology of FABD. METHODS: This double-blind, multicenter, randomized study evaluated the safety and efficacy of a product containing xyloglucan and pea proteins (XG + PP) compared with simethicone, both administered orally (three times daily) for 20 consecutive days. Eighty-eight patients with FABD were randomly assigned to the two groups in a 1:1 ratio. Primary outcome was safety; secondary outcomes were (i) efficacy in alleviating the symptoms of FABD and (ii) efficacy in reducing SIBO, as assessed by hydrogen breath test (HBT). RESULTS: No Adverse Events or Serious Unexpected Adverse Reactions were reported during the study. XG + PP showed a faster onset of action and a significant reduction in bloating and abdominal pain compared with simethicone. At Day 20, XG + PP drastically reduced abdominal girth when compared with simethicone, with an average reduction of 4.7 cm versus 1.8 cm. At Day 20, the XG + PP arm showed a significant reduction in HBT compared to baseline. CONCLUSIONS: This study supports the evidence that FABD patients may benefit from a XG + PP-based treatment that acts on etiology and not just the symptoms.

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

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.