Clinical Trial

Collection of Stool From Healthy Donors for the ex Vivo Study of Shifts of Microbiome Induced by Dairy Phages and Antibiotics: a Model of Bacteria/Host Interaction (DAIRY-SHAPE)

Study acronym: DAIRY-SHAPE
Recruiting
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Summary
The gut microbiota plays a crucial role in health through its involvement in pathogen defense, immune regulation, and nutrient digestion. Microbiota diversity is essential to maintain these functions, and disturbances caused by antibiotic intake or extreme diets can lead to an imbalance (dysbiosis), which is often described as being implicated in numerous diseases as well as in the proliferation of antibiotic-resistant pathogens. The microbiota is defined as the community of microorganisms inhabiting the intestine, including bacteria, viruses, and bacteriophages (phages). These phages, through their ability to destroy the bacteria they infect, play an important role in regulating bacterial populations and could therefore be essential for restoring balance and diversity in the gut. Probiotics, foods that support the microbiota such as dairy products, are of particular interest because the specific interactions between phages and bacteria within these food microbiomes could stimulate microbiota restoration. This study aims to evaluate the effectiveness of phage-based functional foods in restoring intestinal homeostasis and, by extension, improving human health. It will serve as a model to examine how phages present in foods, particularly dairy products, influence gut microbial diversity and to determine whether these phages promote recovery after antibiotic-induced disturbances.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-10-01; most recent amendment 2026-01-12.
Status change: Enrolling by Invitation → Recruiting 2025-11-18
Trial Details
NCT Number NCT07212400
Lead Sponsor Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
Conditions General Population (no Specific Condition or Disease)
Enrollment 4 participants
Start Date 2025-10-16
Primary Completion 2025-11-16 (estimated)
Study Completion 2028-11-16 (estimated)
Updated on ClinicalTrials.gov 2026-01-13