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OpenTrials
Completed

NCT Number: NCT06988514

Stool Collection for Model

Purpose of this study is to collect stool samples from healthy volunteers

Completed

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CEN Experimental

Dijon, 21000, France

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Male and female participants aged between 18-60 years.
  • 18.5 ≤ BMI < 30 kg/m2.
  • Overtly healthy as determined by the Investigator.
  • Regular bowel movements and a mean stool consistency of 3-5 in Bristol Stool Form Scale (BSFS) during the past week.
  • Able to:
  • Collect their stool samples and delivered at site.
  • Speak and read in French.
  • Comply with the study protocol and to commit to the instructions and restrictions.
  • Refrain from any fermented dairy products throughout the study conduct.
  • Refrain from prebiotic, probiotic or synbiotic supplements during the study.
  • Maintain the dose of other consumed supplements during the study.
  • Limit alcohol consumption to ≤ 2 units (i.e., standard glasses) of alcohol per day with a maximum of 10 units per week during the study.
  • Not change substantially their smoking habits during the study.
  • Written informed consent Form (ICF) signed by the participant.
  • No substantial changes in diet and/or physical activity and/or lifestyle habits, defined as start or stop new foods and/or supplements and/or sports and/or daily habits (i.e., travel, sleeping habits) during the study.
  • Have a personal electronic device compatible and connectable to internet to access the web based MyFood24 site when required.
  • Covered by social security or similar system.
  • Agree to be registered in the National biomedical research file for volunteers.

Exclusion criteria

  • Any ongoing metabolic disease, inflammatory disease, hepato-gastrointestinal dis-ease or complications, psychiatric or neurological disorder or other diagnosed by a physician.
  • Any invasive diagnostic and/or therapeutic procedure related to digestion within the past 4 weeks or plan for a digestive surgery during the study, including dental sur-gery, (i.e., from the onset of the wash-out period to the last data collection).
  • General anesthesia during the past 4 weeks or planned during the course of the study.
  • For women in childbearing potential, pregnancy or breastfeeding or plan for preg-nancy during the study.
  • Use of medication that affects the gastrointestinal (GI) function or use of stomach medication within the past 4 weeks or plan to use of any of these during the study.
  • Non-incidental use of > 4 paracetamol tablets (500 mg), nonsteroidal anti-inflammatory drugs (NSAIDs) or aspirin ≤ 2 weeks before the screening visit (V1) or plan of use during the study (if needed, incidental use of ≤ 4 tablets of paracetamol, NSAIDs or aspirin per 2-week period (i.e. ≤ 4 tablets during the refrain period, ≤ 4 tab-lets during the study).
  • Antibiotic, antifungal, antiviral or antiparasitic medication within the past 6 months.
  • Use of any soft drugs, cannabidiol (CBD), plants medicines and/or hard drugs during the study.
  • Participant of another study with investigational or marketed products which could the gut microbiota within the past 4 weeks or plan to participate in such a study dur-ing the study.
  • Participant under guardianship, curatorship, person under judicial protection, family empowerment or future protection mandate.
  • Employees and/or children/family members or relatives of employees of Danone or the participating sites such as medical, pharmacy, dental and nursing students, sub-ordinate hospital and laboratory personnel, employees of the Investigator or of the Sponsor, members of the armed forces, and persons kept in detention.
  • Having received, during the last 12 months, indemnities for participation into clinical study exceeding the annual threshold of 6000€ (including participation to this study).

Treatment and study plan

Standardized stool collection from healthy volunteers

Other

The only interventions are clinical examination, dietary restrictions and samples collection (stool, and urine for the pregnancy tests (when applicable).

Primary outcomes

  1. Collect enough acceptable stool samples

    Time frame: After 14 days of refrain period

Other outcomes

  1. The objective of this study is to collect enough acceptable stool samples from healthy participants to develop the three Danone research applications.

    Time frame: After 14 days of refrain period

    So, the main outcome parameter of this study is the number of acceptable samples for further studies:

    n= 50 samples for the in vitro colonic gas model. n= 72 samples for Danone's sequencing platform. n= 72 samples for Danone's strain collection.

  2. Dietary intakes of the previous day of the faecal samples collection for V2 (collected using my Food24 after sample delivery) and V3 (if applicable).

    Time frame: After 14 days of refrain period

Sponsors and collaborators

Lead sponsor

Danone Global Research & Innovation Center

Industry

Registry information

Official study title

A Single-center, Exploratory, Interventional Clinical Study for Stool Samples Collection in Healthy Participants to Use and Further Advance Some Danone Research Applications

Acronym: StoColM

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 25, 2025
Registry last updated
Jan 6, 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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