NCT02694484

Brief Summary

Fecal microbiota transplantation (FMT) is recommended in the treatment of recurrent Clostridium difficile infection (CDI). The principle is to administer a fecal suspension of a healthy subject (donor) in the digestive tract of a patient with an CDI (receiver). Donors are being clinical and laboratory screening to reduce the likelihood of pathogens transmission (infectious and other). Cytomegalovirus (CMV) is part of the examinations requested by the Agence national de sécurité du médicament et des produits de santé in the context of clinical research. A sero-matching between donor and recipient CMV is requested. This recommendation eliminates many potential donors to a recipient. To date, the frequency detection level of CMV in stool in healthy volunteers with documented positive CMV serology is not known. In addition, CMV transmission risk via the stool is not established. This study aims to determine the detection frequency of CMV in healthy volunteers stool samples selected as potential donors for a FMT and having a positive CMV serology documented

Trial Health

87
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2016

Geographic Reach
1 country

5 active sites

Status
completed

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

First Submitted

Initial submission to the registry

December 7, 2015

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 29, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

July 20, 2025

Status Verified

July 1, 2025

Enrollment Period

1.1 years

First QC Date

December 7, 2015

Last Update Submit

July 16, 2025

Conditions

CMVHealthy Volunteers

Keywords

CytomegalovirusStool sampleHealthy VolunteersFecal microbiota transplant

Outcome Measures

Primary Outcomes (1)

  • Detection frequency of CMV

    Detection frequency of CMV in healthy volunteers stool samples with the selection criteria for the gift of fecal microbiota and having a CMV positive serology

    30 days

Secondary Outcomes (2)

  • Presence of CMV in the stool and in blood.

    At day 30

  • Infectivity of CMV present in faecal

    At day 30

Study Arms (1)

Healthy volunteers

OTHER

For healthy volunteers corresponding to the inclusion criteria it will be taken them Blood and stool samples : a blood sample during the inclusion visit and if they are seropositive for the CMV, it will be taken them another blood sample and they will give a stool sample for the following visit

Other: Blood and stool samples

Interventions

Blood and stool samplesOTHER

Blood sample at Day 1 and blood and stool sample at the next visit

Healthy volunteers

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women aged over 18 and under 65 years
  • Having a normal transit (less than three stools per day and more than three bowel movements per week)
  • Body mass index (BMI) \<30 and\> 16.9
  • Having given and signed informed consent
  • Being affiliated or beneficiary of a social security scheme

You may not qualify if:

  • Taking a treatment with anti-CMV action in three months by acyclovir, valacyclovir, ganciclovir, valganciclovir, foscarnet, cidofovir, brincidofovir
  • Digestive disorders (acute or chronic diarrhea) in the three months prior to donation
  • Known chronic disease (except hypertension and hypercholesterolemia)
  • Documented history of typhoid fever
  • Taking long-term medication (except contraceptives, cholesterol-lowering and antihypertensive treatment)
  • Antibiotic taken within three months
  • Stay in tropics during the three months prior to donation,
  • Residence of several years in tropics (over 24 months)
  • Hospitalization abroad of more than 24 hours in the last 12 months to the donor or his entourage (those living under the same roof)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Centre de biologie pathologie / Laboratoire de virologie

Lille, 59037, France

Location

Cic 1403-Crb Inserm-Chu

Lille, 59037, France

Location

Service des Maladies Infectieuses

Lille, 59037, France

Location

Cic - Inserm - 1435

Limoges, 87042, France

Location

Service de Bactériologie-Virologie-Hygiène/CNR des Cytomégalovirus

Limoges, 87042, France

Location

Related Publications (1)

  • Galperine T, Engelmann I, Hantz S, Postil D, Dewilde A, Deplanque D, Martin R, Labreuche J, Lazrek M, Somers S, Ribot E, Alain S. Cytomegalovirus in donors for fecal microbiota transplantation, the phantom menace? PLoS One. 2023 Jun 29;18(6):e0287847. doi: 10.1371/journal.pone.0287847. eCollection 2023.

    PMID: 37384665RESULT

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Design

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

Study Record Dates

First Submitted

December 7, 2015

First Posted

February 29, 2016

Study Start

June 1, 2016

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

July 20, 2025

Record last verified: 2025-07

Locations

FR(5)