Profiling Fecal Samples for Selection of Donors of Feces | NCT04078581

Studies
Profiling Fecal Samples for Selection of Donors of Feces

NCT04078581

Sponsor

Assistance Publique - Hôpitaux de Paris

Status

Withdrawn

Last Update Posted

Jul 3, 2023Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Fecal Microbiota Transplantation

Interventions

Questionnaire and fecal sample collection

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2019-A01012-55	Other Identifier	ANSM

Status Module

Record Verification Date

Mar 2020

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

COVID-19

Expanded Access Info

Start Date

Mar 2020Estimated

Primary Completion Date

Jun 2021Estimated

Completion Date

Jun 2021Estimated

First Submitted Date

Apr 26, 2019

First Submission Date that Met QC Criteria

Sep 2, 2019

First Posted Date

Sep 6, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 30, 2023

Last Update Posted Date

Jul 3, 2023Actual

Name	Class
Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement	OTHER
University of Paris 5 - Rene Descartes	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
healthy controls	Experimental	Questionnaire and fecal sample collection	Other: Questionnaire and fecal sample collection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Questionnaire and fecal sample collection	Other	Questionnaire and fecal sample collection in order to select donors for FMT.	healthy controls

Outcomes Module

Primary Outcomes

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 Outcomes

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.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Nathalie KAPEL, PharmD, PhD	Assistance Publique - Hôpitaux de Paris	Study Director

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D011795	Surveys and Questionnaires

Ancestor Terms

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms

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Browse Branches

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