Clinical trial NCT02694484: Search Cytomegalovirus in Healthy Volunteers Stools Samples Selected as Potential Donor for Fecal Microbiota Transplant
Official title: Search Cytomegalovirus (CMV) in Healthy Volunteers Stools Samples Selected as Potential Donor for Fecal Microbiota Transplant
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: CMV
Healthy Volunteers
Keywords: Cytomegalovirus
Stool sample
Healthy Volunteers
Fecal microbiota transplant
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
Collaborators: name: University Hospital, Lille
First posted: 2016-02-29
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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


Eligibility 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

Primary outcomes:
measure: Detection frequency of CMV
timeFrame: 30 days
Secondary outcomes:
measure: Presence of CMV in the stool and in blood.
timeFrame: At day 30
measure: Infectivity of CMV present in faecal
timeFrame: At day 30
Other outcomes:
Locations:
city: Lille
country: France
facility: Centre de biologie pathologie / Laboratoire de virologie
city: Lille
country: France
facility: Cic 1403-Crb Inserm-Chu
city: Lille
country: France
facility: Service des Maladies Infectieuses
city: Limoges
country: France
facility: Cic - Inserm - 1435
city: Limoges
country: France
facility: Service de Bactériologie-Virologie-Hygiène/CNR des Cytomégalovirus
Study officials:
References: