Clinical trial NCT06988514: Stool Collection for Model
Official title: A Single-center, Exploratory, Interventional Clinical Study for Stool Samples Collection in Healthy Participants to Use and Further Advance Some Danone Research Applications
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: A03 - Digestive System
03 - Bacteria
Keywords: Stool
Microbiota
In vitro
Lead sponsor: Danone Global Research & Innovation Center
Sponsor class: INDUSTRY
First posted: 2025-05-25
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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


Eligibility criteria: Inclusion Criteria:

1. Male and female participants aged between 18-60 years.
2. 18.5 ≤ BMI \< 30 kg/m2.
3. Overtly healthy as determined by the Investigator.
4. Regular bowel movements and a mean stool consistency of 3-5 in Bristol Stool Form Scale (BSFS) during the past week.
5. 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.
6. Written informed consent Form (ICF) signed by the participant.
7. 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.
8. Have a personal electronic device compatible and connectable to internet to access the web based MyFood24 site when required.
9. Covered by social security or similar system.
10. Agree to be registered in the National biomedical research file for volunteers.

Exclusion Criteria:

1. Any ongoing metabolic disease, inflammatory disease, hepato-gastrointestinal dis-ease or complications, psychiatric or neurological disorder or other diagnosed by a physician.
2. 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).
3. General anesthesia during the past 4 weeks or planned during the course of the study.
4. For women in childbearing potential, pregnancy or breastfeeding or plan for preg-nancy during the study.
5. 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.
6. 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).
7. Antibiotic, antifungal, antiviral or antiparasitic medication within the past 6 months.
8. Use of any soft drugs, cannabidiol (CBD), plants medicines and/or hard drugs during the study.
9. 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.
10. Participant under guardianship, curatorship, person under judicial protection, family empowerment or future protection mandate.
11. 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.
12. Having received, during the last 12 months, indemnities for participation into clinical study exceeding the annual threshold of 6000€ (including participation to this study).

Primary outcomes:
measure: Collect enough acceptable stool samples
timeFrame: After 14 days of refrain period
Secondary outcomes:
Other outcomes:
measure: The objective of this study is to collect enough acceptable stool samples from healthy participants to develop the three Danone research applications.
timeFrame: After 14 days of refrain period
measure: Dietary intakes of the previous day of the faecal samples collection for V2 (collected using my Food24 after sample delivery) and V3 (if applicable).
timeFrame: After 14 days of refrain period
Locations:
city: Dijon
country: France
facility: CEN Experimental
Study officials:
References: