Maternal Probiotic Intervention to Improve Gut Health (MPIGH)

• Status: Not yet recruiting
• Trial end date: 2023-10-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institut Pasteur de Dakar
• Collaborators: Aga Khan University; Bill and Melinda Gates Foundation; International Centre for Diarrhoeal Disease Research, Bangladesh; University of Zambia

Criteria

Inclusion Criteria:

• Women over the age of 18, living in Guediawaye district, Senegal

Exclusion Criteria:

• • 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 non-steroidal anti-inflammatory drugs in the preceding 14 days

• have any illness which in the opinion of the investigator will complicate 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 a plan to leave the study area within the follow-up period

but may be enrolled if/when these disqualifiers have expired.