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Vivomixx for Environmental Enteropathy in Pregnant Women
NCT05501470Phase 2
Key facts
- Status
- Completed
- Start
- Jun 2024
- Primary completion
- Jul 2024
- Countries
- 1
- Sponsor
- Institut Pasteur de Dakar
- Modality
- Live Biotherapeutic Products
- Drugs
- Visbiome
- Conditions
- environmental enteric dysfunction (EED)
01
Overview
Phase 2, randomised trial of Visbiome in environmental enteric dysfunction (EED) (2 arms), sponsored by Institut Pasteur de Dakar. Primary endpoint: Change in inflammation and epithelial damage at 8 weeks. Started Jun 2024; status: completed.
02
Design
2 arms- Study design
- Randomized
Probiotic
Daily dose of Vivomixx for 8 weeks
Placebo
Daily dose of placebo for 8 weeks
03
Who it enrols
Pregnant women over 18 living in Guediawaye district, Senegal, without recent diarrhea or recent use of antibiotics, probiotics, or NSAIDs.
04
Endpoints
Primary
Change in inflammation and epithelial damage
Secondary
Change in enteropathogen colonisation
Impact on the structure and function of the microbiome
Change in permeability
Impact of the host metabolome in pregnant woman
Rate of weight gain in the 2nd trimester of pregnancy
Variability in endpoints across geographies and participating laboratories
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