CClinicalTrials.gg
RecruitingNCT07212400DAIRY-SHAPEUpdated Jan 13, 2026

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)

An observational study in General Population (no Specific Condition or Disease), sponsored by Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement. Recruiting at 1 site in France. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-13.

Sponsored by Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement · Observational

From the registry’s dates

  • Started Oct 2025; still recruiting 11 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
4
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

02

Conditions studied

  • General Population (no Specific Condition or Disease)

Browse trials for

Keywords

  • phages, antibiotics
03

In context

Disease

1,327 studies on the registry are indexed under Disease; 596 are open to participants now.

This study's planned enrollment of 4 is below the median of 215 across 573 observational studies indexed under Disease.

Browse Disease studies →

Lead sponsor

Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement is the lead sponsor of 47 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

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.)
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
4 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Up to 3 years

  2. Secondary Outcome

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

    Time frame: Up to 3 years

07

Study locations

1 of 1 sites recruiting
  • Metagenopolis
    Jouy-en-Josas, 78352, France
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07212400
Lead sponsor
Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
Responsible party
Sponsor
First posted
Oct 8, 2025
Start date
Oct 16, 2025
Primary completion
Nov 16, 2025
Completion
Nov 16, 2028 (estimated)
Last update
Jan 13, 2026

Study contacts

Christian Morabito
Contact
christian.morabito@inrae.fr
0134652210 ext. +33
Eugen PFEIFER, Dr.
study director · Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion