Actively Recruiting
Probiotic For the Improvement of Environmental Enteropathy in Pregnant Women in Senegal
Led by Institut Pasteur de Dakar · Updated on 2025-05-13
76
Participants Needed
1
Research Sites
81 weeks
Total Duration
On this page
Sponsors
I
Institut Pasteur de Dakar
Lead Sponsor
B
Bill and Melinda Gates Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
Stunting in young children refers to attenuated linear growth. In the year 2020, 149.2 million children under the age of 5 were stunted, accounting for 22% of stunting globally. Stunting has short- and long-term consequences of increased morbidity and mortality, impairment of neurocognitive development , impaired responses to oral vaccines, and increased risk of non-communicable diseases. Stunting is partly driven by Environmental Enteric Dysfunction (EED), an enteropathic condition characterised by altered gut permeability, infiltration of immune cells and changes in villous architecture and cell differentiation. EED may help explain why nutritional supplementation either during pregnancy or early childhood has minimal value in correcting childhood stunting. Probiotics may serve to overcome the problem of EED through all mechanisms of pathogenicity, by providing additional bacteria that may help in intestinal decolonization of pathogenic microorganisms (changing the microbiological niche), promoting epithelial healing, improving nutrient absorption, and restoration of an appropriate immune balance between tolerance and responsiveness. This trial will explore the conceptual framework, that a well known probiotic, that can improve the composition of the gut microbiota, can reduce biomarkers of intestinal inflammation and gut health. This will restore healthy microbial signalling to the host epithelium, ameliorate barrier function through secretion of mucus and antimicrobial factors, and improve nutrient availability.
CONDITIONS
Official Title
Probiotic For the Improvement of Environmental Enteropathy in Pregnant Women in Senegal
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women over the age of 18, living in Guediawaye district, Senegal
You will not qualify if you...
- Had diarrhea (three or more loose stools in 24 hours) in the past 14 days
- Taken antibiotics or probiotics in the past 14 days
- Taken non-steroidal anti-inflammatory drugs in the past 14 days
- Have any illness that could affect safety or study results as judged by the investigator
- Have any gastrointestinal condition preventing capsule swallowing (such as obstruction, stricture, fistula, gastroparesis, or swallowing disorder)
- Plan to leave the study area during the follow-up period
AI-Screening
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Trial Site Locations
Total: 1 location
1
Centre de santé de Wakhinane
Guédiawaye, Dakar, Senegal
Actively Recruiting
Research Team
B
Billo TALL, MD
CONTACT
Y
Yakhya Dieye, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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