CompletedNot Applicable

Stool Collection for Model

France110 participantsStarted 2025-06-19

Plain-language summary

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

Age range18 Years – 60 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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:
✓. 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.

✕. 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.

Collect enough acceptable stool samples

Timeframe: After 14 days of refrain period

NCT IDNCT06988514

SponsorDanone Global Research & Innovation Center

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-11-20

Who can participate

Age range18 Years – 60 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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:
✓. 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.

✕. 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.