CTRI/2020/07/026863
Active, not recruiting
Phase 4
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.
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Zydus Healthcare Limited
- Status
- Active, not recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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