NCT06478823

Brief Summary

Currently, ANSM recommendations govern FMT (Fecal Microbiota Transplantation) in clinical trials. The collection and validation of these stool donations as part of the trials is complex and not very efficient. It therefore seems essential to identify the limiting factors and the characteristics of Healthy Volunteer Donors to optimize the number of valid stool donations.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
49mo left

Started Jul 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress31%
Jul 2024May 2030

First Submitted

Initial submission to the registry

June 12, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 27, 2024

Completed
11 days until next milestone

Study Start

First participant enrolled

July 8, 2024

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2030

Last Updated

July 23, 2024

Status Verified

July 1, 2024

Enrollment Period

5.8 years

First QC Date

June 12, 2024

Last Update Submit

July 22, 2024

Conditions

Gastro-Intestinal Disorder

Keywords

Healthy Volunteer stool DonorsStools donationsFecal microbiota transplantation

Outcome Measures

Primary Outcomes (1)

  • Proportion of HVD included who made at least 1 valid stool donation in the 12 months following their inclusion

    A valid stool donation is a donation that complies with all the clinical and biological recommendations of the ANSM Define among the Healthy Volunteer Donors-TMFs (HVD ) included, the number of (HVD ) having made at least 1 valid stool donation.

    12 months

Secondary Outcomes (9)

  • Proportion of "good donors": included donors having made at least 5 valid stool donations in the 12 months following their inclusion.

    12 months

  • Description of the clinical characteristics of HVD performing stool donation

    12 months

  • Description of the lifestyle habits of HVD performing stool donation

    12 months

  • Reasons for non-eligibility during the inclusion visit or during the phone screening

    5 years

  • Factors limiting the number of donations made by HVD per donation period of 28 days maximum

    12 months

  • +4 more secondary outcomes

Study Arms (1)

Healthy volunteers for stool donation

EXPERIMENTAL
Other: Stools donation

Interventions

Stools donationOTHER

Healthy volunteer donors included in the selection process to donate stool for the preparation of a TMF as part of research projects. Donors will be followed from their selection until 6 months after their last valid stool donation.

Healthy volunteers for stool donation

Eligibility Criteria

Age18 Years - 49 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \- Age ≥ 18 years and \< 50 years
  • kg/m² \< body mass index \< 30 kg/m²
  • Regular bowel movement defined as at least 1 stool every other day and maximum 2 stools per day
  • Subject with health insurance (AME excepted)
  • Informed written consent

You may not qualify if:

  • Infectious risk :
  • \- Known HIV, HBV, HCV, HTLV infection
  • \- Residence of more than 2 years in the intertropics zone within the previous 5 years
  • \- Hospitalization abroad for more than 24 hours in the last 12 months (including a member of the healthy volunteers donor's entourage)
  • \- Risk factors for Creutzfeldt-Jakob disease (history: treatment with extractive growth hormone, a family case of transmissible spongiform subacute encephalopathy, surgery with opening of the dura or neurosurgery or invasive brain exploration before 1 January 1995, stay in United Kingdom for a duration greater than 1 year cumulatively between 1980 and 1996 or the presence of neurological or neuropsychiatric scalable recent clinical signs)
  • Previous history of typhoid fever, tuberculosis and malaria
  • Past or current injection drug user or regular use of other drug
  • Gastrointestinal disease:
  • \- Personal or 1st degree family history of: inflammatory bowel disease or celiac disease
  • \- Personal history of irritable bowel syndrome, idiopathic chronic constipation or chronic diarrhea
  • \- Previous history of gastrointestinal neoplasia or polyps
  • \- Family history of 1st degree gastrointestinal neoplasia or polyps before age 60
  • st degree family history of one of the following autoimmune or inflammatory disease : inflammatory arthritis, psoriasis, multiple sclerosis, type I diabetes, spondylitis, lupus and Basedow disease
  • \- If family history unknown in the first degree, the donor is not eligible
  • Previous history of :
  • +39 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LRIPH CRC-Est SAT

Paris, 75012, France

RECRUITING

MeSH Terms

Conditions

Digestive System Diseases

Study Officials

  • Mélissa Montil

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mélissa Montil, Praticien attaché

CONTACT

00 33 1 71 97 08 10melissa.montil@aphp.fr

Harry SOKOL

CONTACT

00 33 1 49 28 31 62harry.sokol@aphp.fr

Study Design

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

Study Record Dates

First Submitted

June 12, 2024

First Posted

June 27, 2024

Study Start

July 8, 2024

Primary Completion (Estimated)

May 1, 2030

Study Completion (Estimated)

May 1, 2030

Last Updated

July 23, 2024

Record last verified: 2024-07

Locations

FR(1)