CMV, Healthy Volunteers
Conditions
Keywords
Cytomegalovirus, Stool sample, Healthy Volunteers, Fecal microbiota transplant
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
Interventions
OTHERBlood and stool samples
Blood sample at Day 1 and blood and stool sample at the next visit
Sponsors
University Hospital, Lille
University Hospital, Limoges
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Detection frequency of CMV | 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
| Measure | Time frame | Description |
|---|---|---|
| Presence of CMV in the stool and in blood. | 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 | At day 30 | Evaluation of the infectivity of CMV present in faecal |
Countries
France
Outcome results
None listed