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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2016 by University Hospital, Limoges
Sponsor:
Collaborator:
University Hospital, Lille
Information provided by (Responsible Party):
University Hospital, Limoges
ClinicalTrials.gov Identifier:
NCT02694484
First received: December 7, 2015
Last updated: August 29, 2016
Last verified: August 2016
  Purpose
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

Condition Intervention
CMV
Healthy Volunteers
Other: Blood and stool samples

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Search Cytomegalovirus (CMV) in Healthy Volunteers Stools Samples Selected as Potential Donor for Fecal Microbiota Transplant

Resource links provided by NLM:


Further study details as provided by University Hospital, Limoges:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.

  • Infectivity of CMV present in faecal [ Time Frame: At day 30 ]
    Evaluation of the infectivity of CMV present in faecal


Estimated Enrollment: 500
Study Start Date: June 2016
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Healthy volunteers
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
Blood sample at Day 1 and blood and stool sample at the next visit

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02694484

Contacts
Contact: Sophie ALAIN, MD 0555056728 sophie.alain@chu-limoges.fr
Contact: Tatiana GALPERINE, MD 0320445743 Tatiana.galperine@chru-lille.fr

Locations
France
Centre de biologie pathologie / Laboratoire de virologie Active, not recruiting
Lille, France, 59037
Cic 1403-Crb Inserm-Chu Recruiting
Lille, France, 59037
Contact: Dominique DEPLANQUE, MD       dominique.deplanque@chru-lille.fr   
Principal Investigator: Dominique DEPLANQUE, MD         
Sub-Investigator: Maria-Claire MIGAUD, MD         
Service des Maladies Infectieuses Active, not recruiting
Lille, France, 59037
Cic - Inserm - 1435 Recruiting
Limoges, France, 87042
Contact: Deborah POSTIL, MD    0555054067    deborah.postil@chu-limoges.fr   
Principal Investigator: Deborah POSTIL, MD         
Sub-Investigator: Thomas LAFIN, MD         
Service de Bactériologie-Virologie-Hygiène/CNR des Cytomégalovirus Active, not recruiting
Limoges, France, 87042
Sponsors and Collaborators
University Hospital, Limoges
University Hospital, Lille
  More Information

Responsible Party: University Hospital, Limoges
ClinicalTrials.gov Identifier: NCT02694484     History of Changes
Other Study ID Numbers: I15033 TRANSFECMV
Study First Received: December 7, 2015
Last Updated: August 29, 2016

Keywords provided by University Hospital, Limoges:
Cytomegalovirus
Stool sample
Healthy Volunteers
Fecal microbiota transplant

ClinicalTrials.gov processed this record on May 25, 2017