Profiling Fecal Samples for Selection of Donors of Feces

Fecal Microbiota Transplantation Clinical Trial

— PROFIT  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04078581
• Other study ID #: APHP190341
• Secondary ID: 2019-A01012-55
• Status: Withdrawn
• Phase: N/A
• Start date: March 2020
• Est. completion date: June 2021

Study information

• Verified date: March 2020
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2021
• Est. primary completion date: June 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fecal Microbiota Transplantation

Intervention

Other:
• Questionnaire and fecal sample collection
Questionnaire and fecal sample collection in order to select donors for FMT.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement, University of Paris 5 - Rene Descartes

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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