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Effect of probiotic vs placebo in Non Constipated Irritable Bowel Syndrome

Phase 4
Active, not recruiting
Conditions
Health Condition 1: K580- Irritable bowel syndrome with diarrheaHealth Condition 2: K582- Mixed irritable bowel syndrome
Registration Number
CTRI/2020/07/026863
Lead Sponsor
Zydus Healthcare Limited
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Closed to Recruitment of Participants
Sex
Not specified
Target Recruitment
0
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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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