Actively Recruiting

Phase 2
Age: 18Years +
FEMALE
NCT05501470

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

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Women over the age of 18, living in Guediawaye district, Senegal
Not Eligible

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

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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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