Status:
COMPLETED
Bifidobacterium Infantis M-63 Improves Mental Health in Irritable Bowel Syndrome Developed After a Major Flood Disaster
Lead Sponsor:
Universiti Sains Malaysia
Collaborating Sponsors:
Morinaga Milk Industry Co., LTD
Conditions:
Irritable Bowel Syndrome
Abdominal Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
A 3-month study was conducted in flood victims from affected villages in the Tumpat district, Kelantan. Participants were given either probiotic, Bifidobacterium infantis M63 (M-63 group) or no probio...
Detailed Description
There is an observed rise in cases of acute gastroenteritis and post-infectious irritable bowel syndrome (PI-IBS) during the peak flood period. One major reason is poor sanitation, water and hygiene p...
Eligibility Criteria
Inclusion
- Adults aged ≥18 years; flood victims who fulfilled the Rome III criteria for IBS developed after flood, able to perform breath-testing, able to provide stool specimens, and able to complete three months of prospective intervention.
Exclusion
- Adults who took antibiotics or probiotics three months prior to and after flood had taken place; previous abdominal surgery and presence of significant medical and psychiatric co-morbidities.
Key Trial Info
Start Date :
September 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT03318614
Start Date
September 1 2015
End Date
December 1 2015
Last Update
October 24 2017
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