Profiling Fecal Samples for Selection of Donors of Feces (PROFIT)

Profiling Fecal Samples to Optimize Selection of Stool Donors for Fecal Microbiota Transplantation

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.

Study Overview

• Status: Withdrawn
• Conditions: Fecal Microbiota Transplantation
• Intervention / Treatment: Other: Questionnaire and fecal sample collection

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nathalie KAPEL, PharmD, PhD; Phone Number: +33 01 42 16 26 56; Email: nathalie.kapel@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: healthy controls; Questionnaire and fecal sample collection	Other: Questionnaire and fecal sample collection; Questionnaire and fecal sample collection in order to select donors for FMT.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dosage of fecal samples with search for differentiated fecal profiles.	16S genomic analysis of microbiota will be performed for the evaluation of alpha and beta diversities of microbiota. Results will be aggregated to define differentiated faecal profiles in healthy volunteers.	At 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dosage of fecal biomarkers with search for differentiated fecal profiles.	Fecal biomarkers such as calprotectin will be dosed. Results will be aggregated to define differentiated faecal profiles in healthy volunteers.	At 12 months
Quantification of colonic inflammation in mouse model.	The quantification of colonic inflammation by myeloperoxidase assay using a sandwich ELISA enzyme-linked immunosorbent assay. Mouse model : authorization APAFlS#7600-20l60620l6336853 v3	At 15 months

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: University of Paris 5 - Rene Descartes; Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
• Investigators: Study Director: Nathalie KAPEL, PharmD, PhD, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2020
• Primary Completion (Estimated): June 1, 2021
• Study Completion (Estimated): June 1, 2021

Study Registration Dates

• First Submitted: April 26, 2019
• First Submitted That Met QC Criteria: September 2, 2019
• First Posted (Actual): September 6, 2019

Study Record Updates

• Last Update Posted (Actual): July 3, 2023
• Last Update Submitted That Met QC Criteria: June 30, 2023
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Healthy volunteers; Fecal microbiota transplantation; Selection of healthy donors; Stool donors
• Other Study ID Numbers: APHP190341; 2019-A01012-55 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No