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

Search Cytomegalovirus (CMV) 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

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers; CMV
• Intervention / Treatment: Other: Blood and stool samples

• Study Type: Interventional
• Enrollment (Actual): 500
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lille, France, 59037
    • Centre de biologie pathologie / Laboratoire de virologie
  • Lille, France, 59037
    • Cic 1403-Crb Inserm-Chu
  • Lille, France, 59037
    • Service des Maladies Infectieuses
  • Limoges, France, 87042
    • Cic - Inserm - 1435
  • Limoges, France, 87042
    • Service de Bactériologie-Virologie-Hygiène/CNR des Cytomégalovirus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of CMV in the stool and in blood.	Evaluation of the link between the presence of CMV in the stool and the detection of CMV viral load in whole blood.	At day 30
Infectivity of CMV present in faecal	Evaluation of the infectivity of CMV present in faecal	At day 30

Collaborators and Investigators

• Sponsor: University Hospital, Limoges
• Collaborators: University Hospital, Lille

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): July 1, 2017
• Study Completion (Actual): July 1, 2017

Study Registration Dates

• First Submitted: December 7, 2015
• First Submitted That Met QC Criteria: February 23, 2016
• First Posted (Estimate): February 29, 2016

Study Record Updates

• Last Update Posted (Actual): July 18, 2017
• Last Update Submitted That Met QC Criteria: July 17, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Healthy Volunteers; Cytomegalovirus; Fecal microbiota transplant; Stool sample
• Other Study ID Numbers: I15033 TRANSFECMV