Status:
COMPLETED
Stool Collection for Model
Lead Sponsor:
Danone Global Research & Innovation Center
Conditions:
A03 - Digestive System
03 - Bacteria
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
Purpose of this study is to collect stool samples from healthy volunteers
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
June 19 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 23 2025
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT06988514
Start Date
June 19 2025
End Date
December 23 2025
Last Update
January 6 2026
Active Locations (1)
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1
CEN Experimental
Dijon, France, 21000