Biofortis
Saint-Herblain, 44800, France
NCT Number: NCT04301973
The purpose of this clinical study is to collect well characterized stools from healthy adult subjects, with completed life habits and alimentary questionnaires.
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Notify Me18 year–69 year
All sexes
Interventional
Not applicable
Saint-Herblain, 44800, France
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
I1. Age between 18 and 69 years (limits included), I2. Body Mass Index (BMI) between 20 and 25 kg/m² (lower limit excluded and upper limit included), I3. Having regular Spontaneous Bowel Movements at the interview (a minimal of 7 SBMs per week is considered as regular);
I4. Ability to follow study procedures including at least:
I7. For female subject: If woman of child bearing age, she must be using or complying with one of the following medically approved methods of contraception such as, but not exclusively:
I8. Good general health in the opinion of the investigator: no clinically significant and relevant abnormalities revealed by medical history or physical examination, I9. Able and willing to participate to the study by complying with the protocol procedures as evidenced by his dated and signed informed consent form, I10. Affiliated with a social security scheme, I11. Agree to be registered in the National biomedical research file for volunteers.
Exclusion criteria
E1. For female subject: pregnant woman or woman planning to become pregnant during the study or breast-feeding woman; E2. Ongoing - diagnosed gastrointestinal acute or chronic disease or complication (e.g; IBS, Crohn's disease, hemorrhoids, …);
E3. Previous (within one month), ongoing or planned therapy during the study with drugs altering bowel function:
E14. Any significant systemic disease such as, but not limited to:
E15. Vulnerable subject defined as individual whose willingness to volunteer in the clinical study may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate. (Examples are members of a group with a hierarchical structure linked to the Investigator or to the Sponsor, such as medical, pharmacy, dental and nursing students, subordinate hospital and laboratory personnel, employees of the Investigator or of the Sponsor, members of the armed forces, and persons kept in detention); E16. Having received, during the last 12 months, indemnities for clinical study higher or equal to 4500 Euros; E17. Subject in a situation which in the investigator's opinion could interfere with optimal participation in the present study or could constitute a special risk for the subject; E18. Under legal protection (guardianship, wardship) or deprived from his rights following administrative or judicial decision; E19. Presenting a psychological or linguistic incapability to sign the informed consent; E20. Impossible to contact in case of emergency.
There is no intervention with a product in this study. The healthy subject has just to come 2 times in the clinical trial unit for clinical exam including urinary pregnancy test, fill life habits and diet questionnaires, and provide one stool sample for the 2nd visit, after 2 weeks of alimentary restrictions.
Time frame: After 14 days
Time frame: After 14 days
Time frame: After 14 days
Time frame: Baseline
Time frame: Baseline and after 14 days
Time frame: Baseline
Danone Global Research & Innovation Center
Industry
Acronym: PEPSIIN
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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