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

U

University of Limoges (UL)

Status

Completed

Conditions

Healthy Volunteers
CMV

Treatments

Other: Blood and stool samples

Study type

Interventional

Funder types

Other

Identifiers

NCT02694484
I15033 TRANSFECMV

Details and patient eligibility

About

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

Enrollment

500 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

500 participants in 1 patient group

Healthy volunteers
Other group
Description:
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
Treatment:
Other: Blood and stool samples

Trial contacts and locations

5

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Data sourced from clinicaltrials.gov

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