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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)

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07212400
Acronym
DAIRY-SHAPE
Enrollment
4
Registered
2025-10-08
Start date
2025-10-16
Completion date
2028-11-16
Last updated
2026-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

General Population (no Specific Condition or Disease)

Keywords

phages, antibiotics

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.

Interventions

None listed

Sponsors

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

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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.)

Design outcomes

Primary

MeasureTime frameDescription
Primary OutcomeUp to 3 yearsTo assess the ability of dairy phages to modulate the intestinal microbiota in vitro using a fermenter system, in the presence and absence of antibiotics.
Secondary OutcomeUp to 3 yearsTo monitor the temporal dynamics of the intestinal microbiota following the addition of dairy phages and antibiotics.

Countries

France

Contacts

Primary ContactChristian Morabito
christian.morabito@inrae.fr0134652210

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026