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

被引：43

作者：

Trifan, Anca ^{[1
]}

Burta, Ovidiu ^{[2
]}

Tiuca, Nicoleta ^{[3
]}

Petrisor, Diana Corina ^{[4
]}

Lenghel, Augustin ^{[5
]}

Santos, Javier ^{[6
]}

机构：

[1] SC Gastromed SRL, Iasi, Romania

[2] Municipal Hosp Dr Gavril Curteanu, Dept Internal Med, Oradea, Romania

[3] Univ Emergency Hosp, Dept Internal Med, Bucharest, Romania

[4] Endodigest Med Clin, Oradea, Romania

[5] CMI Augustin Lenghel, Oradea, Romania

[6] Univ Hosp Vall dHebron, Digest Syst Res Unit, Barcelona, Spain

来源：

UNITED EUROPEAN GASTROENTEROLOGY JOURNAL | 2019年 / 7卷 / 08期

关键词：

Diarrhoea-predominant irritable bowel syndrome; Gelsectan; pea protein and tannins; prebiotics; mucoprotectants; xyloglucan; xylo-oligosaccharide; QUALITY-OF-LIFE; DIAGNOSIS;

D O I：

10.1177/2050640619862721

中图分类号：

R57 [消化系及腹部疾病];

学科分类号：

摘要：

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.

引用

页码：1093 / 1101

页数：9