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)

NCT07212400 | Recruiting

• 1 other identifier: 2025-A00701-48
• Study Type: observational
• Target: 4
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

General Population (no Specific Condition or Disease)

Keywords

phages, antibiotics

Outcome Measures

Primary Outcomes (2)

• Primary Outcome

  To assess the ability of dairy phages to modulate the intestinal microbiota in vitro using a fermenter system, in the presence and absence of antibiotics.

  Up to 3 years

• Secondary Outcome

  To monitor the temporal dynamics of the intestinal microbiota following the addition of dairy phages and antibiotics.

  Up to 3 years

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

General population residing in Paris Region (Ile-de-France)

You may qualify if:

• Age ≥ 18 years and ≤ 60 years
• Varied and balanced omnivorous diet

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement: lead

Study Sites (1)

Metagenopolis

Jouy-en-Josas, 78352, France

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Fecal samples

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Eugen PFEIFER, Dr.

  Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement

  STUDY DIRECTOR

Central Study Contacts

Christian Morabito

CONTACT

0134652210; christian.morabito@inrae.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2025
• First Posted: October 8, 2025
• Study Start: October 16, 2025
• Primary Completion: November 16, 2025
• Study Completion (Estimated): November 16, 2028
• Last Updated: January 13, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)