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)

NCT ID: NCT07212400

Last Updated: 2026-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

4 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-10-16

Study Completion Date

2028-11-16

Brief Summary

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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.

Detailed Description

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Conditions

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General Population (no Specific Condition or Disease)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.)
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eugen PFEIFER, Dr.

Role: STUDY_DIRECTOR

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

Locations

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Metagenopolis

Jouy-en-Josas, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Christian Morabito

Role: CONTACT

0134652210 ext. +33

Other Identifiers

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2025-A00701-48

Identifier Type: -

Identifier Source: org_study_id

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