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Completed

NCT Number: NCT02694484

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

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

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Key information

Conditions

CMV Healthy Volunteers

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre de biologie pathologie / Laboratoire de virologie, Lille, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • Accept the constraints of the study, ie two visits (inclusion and Following Visit), a stool sample, two blood tests
  • Having given and signed informed consent
  • Being affiliated or beneficiary of a social security scheme

Exclusion criteria

  • Taking a treatment with anti-CMV action in three months by acyclovir, valacyclovir, ganciclovir, valganciclovir, foscarnet, cidofovir, brincidofovir
  • Having an absolute exclusion criteria to donation defined by the survey of French Group Fecal Transplant:
  • 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)
  • Healthy Volunteers who have not reached the limit of compensation by social security or exclusion period

Treatment and study plan

Blood and stool samples

Other

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

Primary outcomes

  1. Detection frequency of CMV

    Time frame: 30 days

    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

Secondary outcomes

  1. Presence of CMV in the stool and in blood.

    Time frame: At day 30

    Evaluation of the link between the presence of CMV in the stool and the detection of CMV viral load in whole blood.

  2. Infectivity of CMV present in faecal

    Time frame: At day 30

    Evaluation of the infectivity of CMV present in faecal

Sponsors and collaborators

Lead sponsor

University Hospital, Limoges

Other

Collaborators

  • University Hospital, Lille

Registry information

Official study title

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

Acronym: TRANSFECMV

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Feb 29, 2016
Registry last updated
Jul 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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