CTRI/2020/07/026863进行中（未招募）4 期
Multicentric, Phase IV, randomized, double blind, placebo controlled trial to assess effectiveness and safety of Lactobacillus acidophilus LA-5® and Bifidobacterium BB-12® in the treatment of Non-Constipated Irritable Bowel Syndrome in adults aged 18 years to 65 years.
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
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
入选标准
- •1. Subjects in the age group of 18-65 years (both ages inclusive) with a positive diagnoses of non-constipated IBS ) diagnosed based on responses to the Enhanced Asian ROME 3 Questionnaire
- •2. Criteria fulfilled for the last 3 months with symptom onset at least 6 months before study.
- •3. Able to provide signed informed consent and be able to comply with study procedures
排除标准
- •1.Subjects with Constipation Predominant IBS (IBS-C)
- •2.Subjects with history of major abdominal surgery, a history of inflammatory bowel disease or diverticular disease, celiac disease, structural abnormalities of the gastrointestinal tract other than oesophagitis or gastritis allergic diseases.
- •3.Other organic or major psychiatric disorders such as schizophrenia manic depressive conditions as assessed by medical history, appropriate consultations and laboratory tests. 4.Faecal occult blood test positive
- •5.Pregnant or Lactating mothers
- •6.Any other medical condition in the opinion of the investigator rendering the subject ineligible to participate.
- •7.Use of antibiotics or probiotics in the three weeks preceding study start.
研究者
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