Status:
COMPLETED
Multi-strain Probiotic in the Management of IBS-D
Lead Sponsor:
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Conditions:
Irritable Bowel Syndrome
Eligibility:
All Genders
18-55 years
Phase:
PHASE4
Brief Summary
1. To assess the effect of multistrain probiotics on abdominal pain using a validated symptom severity score in IBS patients. 2. To assess the efficacy of a multi-strain probiotic supplement as a trea...
Detailed Description
Background: Accumulating evidence supports the view that an imbalance of gut bacteria contributes to IBS, and that increasing the mass of beneficial species may reduce the numbers of pathogenic bacter...
Eligibility Criteria
Inclusion
- Diagnosed case of IBS using Rome III criteria
- Absence of red flag sign: anemia, fever, wt loss, per rectal bleeding, nocturnal frequency, family history of inflammatory bowel disease (IBD), cancer
- Age 18-55 years
- No probiotics used in prior 3 months.
- Agreed not to start any other drug unless clinically indicated.
- No antibiotics in previous 2 months of enrolment.
Exclusion
- Age\<18 or \>55 years
- Previous treatment with probiotics within last 3 months
- Pregnant or lactating females
- Concurrent severe illness (Uncontrolled diabetes mellitus, Renal Dysfunction, Liver disease, hyper and hypothyroidism)
- Chronic organic bowel disorders e.g. inflammatory bowel diseases, tuberculosis, Diverticular disease etc
- Any previous gastrointestinal surgery
Key Trial Info
Start Date :
April 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2016
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT03251625
Start Date
April 1 2015
End Date
April 1 2016
Last Update
February 5 2018
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