Stool Collection for Model (StoColM)

Danone Global Research & Innovation Center

Status

Completed

Conditions

A03 - Digestive System

03 - Bacteria

Treatments

Other: Standardized stool collection from healthy volunteers

Study type

Interventional

Funder types

Industry

Identifiers

NCT06988514

24REX0077603

Details and patient eligibility

About

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

Enrollment

110 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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).