Status:
RECRUITING
Maternal Probiotic Intervention to Improve Gut Health-Trial II-Pakistan
Lead Sponsor:
Aga Khan University
Collaborating Sponsors:
Bill and Melinda Gates Foundation
International Centre for Diarrhoeal Disease Research, Bangladesh
Conditions:
Environmental Enteric Dysfunction (EED)
Stunting
Eligibility:
FEMALE
18-49 years
Phase:
PHASE2
Brief Summary
Burden: Environmental Enteric Dysfunction (EED) is an enteropathic condition characterised by altered gut permeability, infiltration of immune cells, and changes in villous architecture and cell diffe...
Detailed Description
A total of 144 pregnant women in their second trimester will be enrolled. Subsequently, 96 will be randomized to receive an antibiotic for 5 days, followed by a 1-day washout period (1 week), and then...
Eligibility Criteria
Inclusion
- 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
- 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.
- Presence of any of the following WASH conditions -
- use surface water, unimproved water, or limited water for drinking; OR
- use surface water, unimproved water, or limited water for cooking; OR
- use surface water, unimproved water, or limited water for washing utensils; OR
- practice open defecation, use unimproved sanitation (toilet facility), or limited sanitation (toilet facility); OR
- 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 :
August 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
144 Patients enrolled
Trial Details
Trial ID
NCT07207434
Start Date
August 30 2025
End Date
December 31 2026
Last Update
October 6 2025
Active Locations (1)
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1
Mother and Child Health Research and Training Center, AKU
Matiari, Sindh, Pakistan, 71000