Z Gastroenterol 2025; 63(08): e367-e368
DOI: 10.1055/s-0045-1810636
Abstracts | DGVS/DGAV
Freie Vorträge

Efficacy and safety of Xyloglucan (XG), pea protein and tannins (PPT), and Xylo-oligosaccharides (XOS) for diarrhoea-predominant irritable bowel syndrome: a randomised, crossover clinical trial

Authors

  • S Bradic

    1   Reckitt Benckiser Deutschland GmbH, Medical Affairs DACH, Heidelberg, Deutschland
  • W Malik

    2   Reckitt Benckiser Healthcare UK Ltd., Slough, UK, Medical Affairs, Slough, Vereinigtes Königreich
  • J Wray

    2   Reckitt Benckiser Healthcare UK Ltd., Slough, UK, Medical Affairs, Slough, Vereinigtes Königreich
  • S Casella

    3   Devintec Pharma, Lugano, Lugano, Schweiz
  • G Bramati

    3   Devintec Pharma, Lugano, Lugano, Schweiz
  • B Karnani

    3   Devintec Pharma, Lugano, Lugano, Schweiz
 

Background: Irritable bowel syndrome (IBS) is highly prevalent and poses a significant clinical challenge. Gavidarm is a medical device containing xyloglucan (XG), pea protein and grape seed extract containing tannins (PPT) and xylo-oligosaccharides (XOS), which act synergistically to protect and strengthen the intestinal barrier.

Objective: The objective of this study is to evaluate the efficacy and safety of XG+PPT+XOS in adult patients with diarrhoea predominant IBS (IBS-D).

Methods: This double-blind study involved 60 patients who were randomly assigned to receive either XG+PPT+XOS or placebo for 28 days, then crossed over to the alternative treatment. After the end of treatment, patients were observed for a follow-up period of 60 days.

Results: At Day 28, a significantly higher proportion of patients starting treatment with XG+PPT+XOS showed normal stool consistency (Bristol Stool Form Scale type 3-4) compared to placebo (87% vs 0%; p=0.0019). At Day 56, a significantly greater proportion of patients who crossed over to XG+PPT+XOS presented normal stools, compared to placebo (93% vs 23%; p=0.0001). In the group that initially received placebo and then switched to XG+PPT+XOS, symptoms’ improvement was maintained during the follow-up period. Subjective assessments of abdominal pain, bloating, quality of life and general health showed a significant improvement with XG+PPT+XOS over placebo. No adverse events related to treatment were reported.

Conclusion: XG+PPT+XOS effectively controlled diarrhoea and alleviated clinical symptoms in patients with IBS-D and was well tolerated.

Präsentiert in der Sitzung: Was tun beim Reizdarm? Von der Frustration zur Evidenz

Donnerstag, 18. September 2025, 14:30 – 16:00, MZF 2



Publikationsverlauf

Artikel online veröffentlicht:
04. September 2025

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