Long-term safety and efficacy study of a medical device containing xyloglucan, pea protein reticulated with tannins and xylo-oligosaccharides, in patients with diarrhoea-predominant irritable bowel syndrome.

BACKGROUND

Irritable bowel syndrome with diarrhoea (IBS-D) is a frequent problem associated with a significant socioeconomic implication. Increased gut permeability is an important pathophysiological mechanism. A medical device containing xyloglucan (XG), pea protein and tannins (PPT) from grape-seed extract, and xylo-oligosaccharides (XOS) has proven restoration of intestinal barrier function. Our objective was to evaluate the efficacy and safety of treatment with the medical device XG + PPT + XOS (XG-PPT-XOS) in adult patients with IBS-D in a clinical setting for 6 months.

MATERIAL AND

METHODS

This was a multicentre, open-label, prospective, observational study conducted to evaluate long-term safety and efficacy of XG-PPT-XOS. IBS-D adult patients (Rome IV criteria) were included and received two tablets twice daily for 6 months. IBS Symptom Severity Score (IBS-SSS) and bowel habit were registered at baseline and monthly, until the end of follow up. Efficacy was evaluated by comparison of mean scores at each time point.

RESULTS

50 patients were included, of which 19 completed the 6 months. IBS-SSS score decreased from 312.2 ± 82.2 to 213.6 ± 109.9 (p < 0.0001) at 1 month and 192.0 ± 108.9 at the last visit completed; diarrhoea score decreased from 45.6 ± 17.9 to 25.7 ± 17.7 and 25.3 ± 17.2 at 1 month and at the last visit completed, respectively. Pain score decreased from 107.8 ± 49.9 at baseline to 73.2 ± 57.3 (p < 0.0001) at 1 month and bloating score from 56.4 ± 28.8 at baseline to 42.8 ± 32.6 (p < 0.001) at 1 month, reaching 62.4 ± 56.0 and 40.4 ± 34.3, respectively, at the last visit completed. Adverse effects were mild and mostly not related to treatment.

CONCLUSION

Treating IBS-D patients with XG-PPT-XOS is effective and safe in the long term within a clinical setting, improving all IBS-D symptoms from the first month of treatment and showing a sustained response over the term of therapy.