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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02694484
Other study ID # I15033 TRANSFECMV
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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