RecruitingPhase 2NCT05501470

Probiotic For the Improvement of Environmental Enteropathy in Pregnant Women in Senegal

Ability of the Probiotic Vivomixx to Improve Environmental Enteropathy in Pregnant Women: a Proof of Concept Trial in Senegal


Sponsor

Institut Pasteur de Dakar

Enrollment

76 participants

Start Date

Jun 6, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria1

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

Exclusion Criteria7

  • • 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.

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Interventions

DRUGProbiotic

Probiotic

DRUGPlacebo

Placebo

DEVICECapScan®

The only non-standard sample collection instrument is the CapScan® device. The CapScan Collection Capsule ("Capsule") is a non-invasive device that collects gastrointestinal samples along the GI tract that are then analyzed outside the body. Samples collected by the Capsule will be expressed, then undergo DNA sequencing and mass spectrometric analysis to determine the identity and function of the bacterial and host cells in the different regions of the GI tract and compared to similar analyses conducted on concomitantly collected stool samples.


Locations(1)

Centre de santé de Wakhinane

Guédiawaye, Dakar, Senegal

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NCT05501470


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