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)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: General Population (no Specific Condition or Disease). Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Primary outcome measures
- Primary Outcome [Time frame: Up to 3 years]
- Secondary Outcome [Time frame: Up to 3 years]
Eligibility criteria
Inclusion criteria
- Age ≥ 18 years and ≤ 60 years
- Varied and balanced omnivorous diet
Exclusion criteria
- Vegetarian, vegan, or restrictive diet
- Use of medications (antibiotics, anti-inflammatory drugs, immunosuppressants, and/or probiotics, prebiotics, or synbiotics), either as drugs or dietary supplements, within the 3 months prior to sample collection
- Pregnant and/or breastfeeding women
- Presence of an acute or chronic disease (gastrointestinal, metabolic, immune, or inflammatory), diagnosed or suspected
- Colonoscopy within the past 3 months
- Known food allergy or intolerance (e.g., gluten, lactose, FODMAPs) that may alter the usual diet and/or microbiota composition
- Individuals under legal protection (guardianship, trusteeship, etc.)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- Metagenopolis — Jouy-en-Josas
Identifiers
NCT: NCT07212400 · 2025-A00701-48