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

Autor: Carlos Teruel, Blanca Serrano Falcón, Esperanza Pérez, Enrique Rey, Constanza Ciriza de los Ríos, Fernando Geijo, Federico Argüelles-Arias
Přispěvatelé: Universidad de Sevilla. Departamento de Medicina
Rok vydání: 2021
Předmět:
Zdroj: Therapeutic Advances in Gastroenterology, Vol 14 (2021)
Therapeutic Advances in Gastroenterology
ISSN: 1756-2848
DOI: 10.1177/17562848211020570
Popis: 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 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.
Databáze: OpenAIRE