Status:
UNKNOWN
Maternal Probiotic Intervention to Improve Gut Health
Lead Sponsor:
International Centre for Diarrhoeal Disease Research, Bangladesh
Collaborating Sponsors:
Bill and Melinda Gates Foundation
Conditions:
Environmental Enteric Dysfunction
Gut Microbiota Dysbiosis
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
This trial will determine if a well-established probiotic, Vivomixx, can modulate maternal microbiota and ameliorate maternal environmental enteropathy which compromises growth in the first 1000 days....
Detailed Description
Stunting in young children refers to attenuated linear growth. In the year 2020, 149.2 million children under the age of 5 years of age were stunted, accounting for 22% of stunting globally. Stunting ...
Eligibility Criteria
Inclusion
- Women aged 18 years or older in the first trimester or early second trimester of pregnancy, living in defined geographical areas of Bangladesh (Matlab), Pakistan, Senegal and Zambia, where it can be assumed that environmental enteropathy is universal
Exclusion
- Potential participants will not be enrolled if they:
- have had diarrhea, defined as the passage of three or more loose stools per 24 hours, in the preceding 14 days
- have taken antibiotics or probiotics in the preceding 14 days
- have taken steroids or non-steroidal anti-inflammatory drugs in the preceding 14 days
- have severe pallor (hemoglobin concentration \<8g/dl)
- have any chronic disease, illness or condition which in the opinion of the investigator will complicate the assessment of safety or efficacy
- have any gastrointestinal contraindication to ingestion of a capsule (known or suspected gastrointestinal obstruction, stricture, fistula, gastroparesis, or any swallowing disorder)
- have the plan to observe fast at any time during the intervention period
- have the plan to leave the study area within the follow-up period
- are included in any other intervention trial
- belong to a household from which another woman is already enrolled in the study
- but may be enrolled if/when these disqualifiers have expired
Key Trial Info
Start Date :
June 22 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2025
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT06196450
Start Date
June 22 2023
End Date
March 31 2025
Last Update
January 17 2024
Active Locations (1)
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1
International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b)
Chāndpur, Bangladesh