Status:
RECRUITING
Maternal Probiotic Intervention to Improve Gut Health - Trial II - Burkina Faso (MPIGH-II)
Lead Sponsor:
University Ghent
Collaborating Sponsors:
Institut de Recherche en Sciences de la Santé (IRSS)
Agence de Formation, de Recherche & d'Expertise en Santé pour l'Afrique (AFRICSanté)
Conditions:
Environmental Enteric Dysfunction (EED)
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
Burden: Environmental Enteric Dysfunction (EED) is an enteropathic condition characterized by altered gut permeability, infiltration of immune cells and changes in villous architecture and cell differ...
Detailed Description
Across the site, pregnant women will be screened for eligibility in their first or early second trimester of pregnancy (13-17 weeks of GA) and will be enrolled and randomized into three arms (48 women...
Eligibility Criteria
Inclusion
- All pregnant women in their first or early second trimester of pregnancy, residing in the icddr,b service area of Matlab, who meet the eligibility criteria decribed below.
- Inclusion criteria
- Women aged 18 years or older in their first or early second trimester of pregnancy (13-17 weeks of gestational age \[GA\]), living in defined geographical areas of Bangladesh (Matlab), Pakistan, Zambia, and Burkina Faso, where it can be assumed that environmental enteropathy is prevalent
- AND
- Presence of any 2 out of 11 selected bacterial pathogen targets (Aeromonas, Campylobacter coli, Campylobacter jejuni, Campylobacter Pan, Enteroaggregative Escherichia coli, Enteropathogenic Escherichia coli, Enterotoxigenic Escherichia coli, Plesiomonas, Shigella\_EIEC, Salmonella and Klebsiella pneumoniae in fecal samples measured by TAC-qPCR.
- AND
- Presence of any of the following WASH conditions -
- 1\. use surface water, unimproved water, or limited water for drinking; OR 2. use surface water, unimproved water, or limited water for cooking; OR 3. use surface water, unimproved water, or limited water for washing utensils; OR 4. practice open defecation, use unimproved sanitation (toilet facility), or limited sanitation (toilet facility); OR 5. lack facility or have limited facility for handwashing
- Exclusion criteria
- Potential participants will not be enrolled if they:
- have MUAC ≥30 cm
- are carrying more than one fetus (i.e., multiple pregnancy)
- have diarrhea, defined as the passage of three or more loose stools per 24 hours, or have had diarrhea in the preceding 14 days
- have fever or an active infection
- 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 anemia as determined using finger stick Hb \< 8 g/dl
- have a history of chronic digestive disease
- have any gastrointestinal contraindication to ingestion of a capsule (known or suspected gastrointestinal obstruction, stricture, fistula, gastroparesis, or any swallowing disorder)
- have known immunocompromised status (known history of HIV infection, autoimmune disease, diabetes mellitus, etc.)
- have known drug hypersensitivity/allergy/intolerance
- have chronic disease or any other illness or condition which in the opinion of the investigator will complicate the assessment of safety or efficacy
- are medically disqualified: Any potential participant who is deemed medically unfit for trial enrollment by a non-study healthcare provider, due to the presence of severe or unstable health conditions that could compromise safety or interfere with the study outcomes, will be excluded from participation
- have a plan to observe fast any time during the intervention period
- have a plan to leave the study area within the follow-up period
- are participating in any other interventional 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.
Exclusion
Key Trial Info
Start Date :
July 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 7 2027
Estimated Enrollment :
144 Patients enrolled
Trial Details
Trial ID
NCT07134790
Start Date
July 30 2025
End Date
June 7 2027
Last Update
November 17 2025
Active Locations (1)
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1
Agence de Formation de Recherche et d'Expertise en Santé pour l'Afrique
Bobo-Dioulasso, Burkina Faso