Maternal Probiotic Intervention to Improve Gut Health (MPIGH)
Status:
Not yet recruiting
Trial end date:
2023-10-01
Target enrollment:
Participant gender:
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
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