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Search Cytomegalovirus in Healthy Volunteers Stools Samples Selected as Potential Donor for Fecal Microbiota Transplant

NCT02694484 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2025-07-20

No results posted yet for this study

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

Conditions

  • CMV
  • Healthy Volunteers

Interventions

OTHER

Blood and stool samples

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

Sponsors & Collaborators

  • University Hospital, Lille

    collaborator OTHER

  • University Hospital, Limoges

    lead OTHER

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2017-07-31
Completion
2017-07-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02694484 on ClinicalTrials.gov