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临床试验/NCT03174561
NCT03174561Unknown不适用

Clinical Assessment of the Benefits of the Combination Inuline, Choline and Silymarin in Mitigating the Symptomatology in Patients With Irritable Bowel Syndrome

SC Fiterman Pharma SRL1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2017年5月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
50
试验地点
1
主要终点
IBS symptoms severity score

研究概览

简要总结

The study investigate the efficacy of the combination inuline, choline and silymarin in alleviating the symptomatology of the patients with irritable bowel syndrome with constipation in a randomized, cross-over, no treatment controlled study.

详细描述

In this study patients diagnosed using Rome IV criteria with irritable bowel syndrome with constipation are included. The study was approved by the Ethic Committee of the University of Medicine and Pharmacy "Gr. T Popa" Iasi to be conducted at the Institute of Gastroenterology and Hepatology of Clinical Emergency Hospital "Sf. Spiridon" Iasi. The patients are assigned after a randomized scheme to one of the groups: diet restriction scheme or diet restriction scheme plus a product with inuline, choline and silymarin. After 28 days the patients are crossed between the groups and followed for additional 28 days diet scheme with or without inuline, choline and silymarin supplementation. All the patients are evaluated initially, in the day 28 and in the day 57 for the stool habits, stool characteristics using Brystol Scale and symptoms severity (abdominal pain, frequency of abdominal pain, bloating severity, patients satisfaction in relation with stool frequency and the impact of IBS on daily activity) as appreciated by the patients for the last 10 days.

The acquired data will be analyzed and published.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged 18-75 years, diagnosed with Irritable Bowel Syndrome using Roma IV criteria

排除标准

  • Patients with IBS with predominant diarrhea or mixt symptoms
  • Patients with known hypersensitivity to any of the ingredients of the dietary supplement
  • Patients who used prebiotic, probiotic or laxative products in the last 10 days
  • Pregnancy and lactation

结局指标

主要结局

IBS symptoms severity score

时间窗: the last 10 days

visual analogue scale for IBS symptoms severity will be used

number of bowel movements

时间窗: the last 7 days

number of bowel movements/week

次要结局

未报告次要终点

研究者

发起方
SC Fiterman Pharma SRL
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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