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临床试验/IRCT20200915048727N1
IRCT20200915048727N1招募中3 期

Effects of supplementation with a multi-species probiotic formulation (BioIBS®) on severity of symptoms and quality of life in patients with irritable bowel syndrome

Shahid Beheshti University of Medical Sciences0 个研究点目标入组 60 人开始时间: 待定最近更新:
适应症

试验速览

阶段
3 期
状态
招募中
入组人数
60

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
18 years 至 75 years(—)
性别
All

入选标准

  • Presence of Rome IV diagnostic criteria for IBS
  • male and female subjects in age range of 18-75 years.

排除标准

  • Anemic subjects with Hb < 10 g/dl.
  • Subjects with organic disease (to be ruled out by physician based on prior history and physical examination).
  • Subjects with a history of surgical resection of the stomach, small intestine or large intestine.
  • Subjects with a history of or complications from inflammatory bowel disease (Crohn's disease or ulcerative colitis) and ischemic colitis.
  • Subjects with complications from infectious enteritis, hyperthyroidism or hypothyroidism.
  • Subjects with a history of any diet-based intolerance (gluten or lactose intolerance).
  • Subjects who are pregnant or planning on becoming pregnant throughout the course of the study.
  • Subjects with uncontrolled Type II diabetes mellitus.
  • Subjects who are immuno-compromised
  • Subjects who have used an over-the-counter or prescription laxative medication or any other herbal agents affecting GI motility within 2 weeks prior to screening.
  • Subjects who have used probiotic or fiber supplements (or probiotic/fiber enriched foods) or an antibiotic within 4 weeks prior to screening.
  • Subjects who have used IBS specific treatments within 4 weeks prior to screening.
  • Subjects who have participated in a clinical research trial within 30 days prior to randomization.

研究者

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