Clinical trial NCT04078581: Profiling Fecal Samples for Selection of Donors of Feces
Official title: Profiling Fecal Samples to Optimize Selection of Stool Donors for Fecal Microbiota Transplantation
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Fecal Microbiota Transplantation
Keywords: Selection of healthy donors
Healthy volunteers
Stool donors
Fecal microbiota transplantation
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
name: University of Paris 5 - Rene Descartes
First posted: 2019-09-06
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: Fecal microbiota transplantation (FMT) represents a promising therapeutic in numerous clinical situations associated with dysbiosis. Today, this procedure is recommended in patients with recurrent Clostridioides difficile infections but beneficial effects of FMT have also been described in other diseases associated with intestinal dysbiosis .... A donor effect which could be related to the inter-individual variability of microbiota and microbiome leading to specific metabolic capacities may influence the efficacy of the procedure.

Detailed description: Fecal microbiota transplantation (FMT) represents a promising therapeutic in numerous clinical situations associated with dysbiosis. Today, this procedure is recommended in patients with recurrent Clostridioides difficile infections but beneficial effects of FMT have also been described in other diseases associated with intestinal dysbiosis .... A donor effect which could be related to the inter-individual variability of microbiota and microbiome leading to specific metabolic capacities may influence the efficacy of the procedure. The aim of our study is to measure fecal biochemical, microbial and immunological parameters that are known to influence gut homeostasis in a group of 40 healthy donors to establish a referential profile of human stools to optimize donor profiling, beyond the infectious parameters, to increase the success rate of FMT.

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years
2. Healthy volunteers
3. Participant having been informed of the study and having sign a consent to participation
4. Patient affiliated with a social security or beneficiary of such a social protection

Exclusion Criteria:

1. Person subject to legal protection (guardianship, trusteeship, etc.)
2. Chronic disease that can alter the intestinal microbiota: cancer or malignant disease, bowel disease, diabetes, hypertension, hypercholesterolemia, ....
3. Presence in the 1st degree family of one of the chronic diseases mentioned above
4. Blood in stools
5. Chronic drug treatment likely to alter the intestinal microbiota
6. Travel to a tropical country in the last 3 months or extended stay (\> 3 months) for less than 1 year
7. Hospitalization abroad (\> 24h) in the last 12 months
8. Hospitalization abroad (\> 24h) of a family member living under the same roof during the last 12 months
9. Medical consultation in the last 3 months (other than administrative)
10. Contact with a person with an infectious or contagious disease for more than 3 months
11. Digestive disorders / febrile gastroenteritis (diarrhea with fever) in the last 3 months
12. Febrile illnesses for more than 3 months
13. Antibiotic treatment in the last 3 months
14. Treatment with PPIs in the last 3 months

Primary outcomes:
measure: Dosage of fecal samples with search for differentiated fecal profiles.
timeFrame: At 12 months
Secondary outcomes:
measure: Dosage of fecal biomarkers with search for differentiated fecal profiles.
timeFrame: At 12 months
measure: Quantification of colonic inflammation in mouse model.
timeFrame: At 15 months
Other outcomes:
Locations:
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Nathalie KAPEL, PharmD, PhD
role: STUDY_DIRECTOR
References: