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
收藏
页码：1093 / 1101
页数：9
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