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NCT Number: NCT07212400

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)

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Metagenopolis

Jouy-en-Josas, 78352, France

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

Primary outcomes

  1. Primary Outcome

    Time frame: Up to 3 years

    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.

  2. Secondary Outcome

    Time frame: Up to 3 years

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

Study contacts

Contact information is provided by the study sponsor or research team.

Christian Morabito

CONTACT

[email protected]

0134652210 ext. +33

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study 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

Acronym: DAIRY-SHAPE

Important dates

Study start
2025
Primary completion
2025
Study completion
2028
First posted
Oct 8, 2025
Registry last updated
Jan 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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