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

Healthy Volunteers Clinical Trial

— TRANSFECMV  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02694484
• Other study ID #: I15033 TRANSFECMV
• Status: Completed
• Phase: N/A
• First received: December 7, 2015
• Last updated: July 17, 2017
• Start date: June 2016
• Est. completion date: July 2017

Study information

• Verified date: July 2017
• Source: University Hospital, Limoges
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• CMV
• Healthy Volunteers

Intervention

Other:
• Blood and stool samples
Blood sample at Day 1 and blood and stool sample at the next visit

Locations

Country	Name	City	State
France	Centre de biologie pathologie / Laboratoire de virologie	Lille
France	Cic 1403-Crb Inserm-Chu	Lille
France	Service des Maladies Infectieuses	Lille
France	Cic - Inserm - 1435	Limoges
France	Service de Bactériologie-Virologie-Hygiène/CNR des Cytomégalovirus	Limoges

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Limoges	University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Infectivity of CMV present in faecal	Evaluation of the infectivity of CMV present in faecal	At day 30