CompletedNot Applicable

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

France500 participantsStarted 2016-06

Plain-language 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

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Detection frequency of CMV

Timeframe: 30 days

Trial details

NCT IDNCT02694484

SponsorUniversity Hospital, Limoges

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-07

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