Profiling Fecal Samples for Selection of Donors of Feces

NCT04078581 | Withdrawn

• 2 other identifiers: APHP1903412019-A01012-55
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Fecal Microbiota Transplantation

Keywords

Selection of healthy donors; Healthy volunteers; Stool donors; Fecal microbiota transplantation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Dosage of fecal biomarkers with search for differentiated fecal profiles.

  At 12 months

• Quantification of colonic inflammation in mouse model.

  At 15 months

Study Arms (1)

healthy controls

EXPERIMENTAL

Questionnaire and fecal sample collection

Other: Questionnaire and fecal sample collection

Interventions

Questionnaire and fecal sample collection OTHER

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

healthy controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement: collaborator
• University of Paris 5 - Rene Descartes: collaborator

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Nathalie KAPEL, PharmD, PhD

  Assistance Publique - Hôpitaux de Paris

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2019
• First Posted: September 6, 2019
• Study Start: March 1, 2020
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: July 3, 2023

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share