CMVTRANSFECMVNCT02694484
Search Cytomegalovirus in Healthy Volunteers Stools Samples Selected as Potential Donor for Fecal Microbiota Transplant
A study testing Blood and stool samples in people with CMV and Healthy Volunteers, run by University Hospital, Limoges at 5 sites in France.
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). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- CMV, Healthy Volunteers
- What is being tested?
- Blood and stool samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 5 sitesFrance
- Study dates
- Jun 2016to Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 11Show fewer
- 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 locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Centre de biologie pathologie / Laboratoire de virologie
Lille, 59037
Cic 1403-Crb Inserm-Chu
Lille, 59037
Service des Maladies Infectieuses
Lille, 59037
Cic - Inserm - 1435
Limoges, 87042
Service de Bactériologie-Virologie-Hygiène/CNR des Cytomégalovirus
Limoges, 87042
About this study
Official title: Search Cytomegalovirus (CMV) in Healthy Volunteers Stools Samples Selected as Potential Donor for Fecal Microbiota Transplant
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
- Conditions
- CMV, Healthy Volunteers
- Being tested
- Blood and stool samples
- Keywords
- Cytomegalovirus, Stool sample, Healthy Volunteers, Fecal microbiota transplant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood and stool samplesOther
Blood sample at Day 1 and blood and stool sample at the next visit
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | Other | 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 Receives: Other: Blood and stool samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 days
Secondary outcomes (2)
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.
Measured: At day 30
Infectivity of CMV present in faecal
Evaluation of the infectivity of CMV present in faecal
Measured: At day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2016 (estimated)
- Study startJun 2016
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CMVStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Lille
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02694484
- Sponsor's protocol ID
- I15033 TRANSFECMV
- Acronym
- TRANSFECMV
- Status last verified
- Jul 2025
- First submitted
- 7 Dec 2015
- Last updated
- 20 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Galperine T, Engelmann I, Hantz S, Postil D, Dewilde A, Deplanque D, Martin R, Labreuche J, Lazrek M, Somers S, Ribot E, Alain S. Cytomegalovirus in donors for fecal microbiota transplantation, the phantom menace? PLoS One. 2023 Jun 29;18(6):e0287847. doi: 10.1371/journal.pone.0287847. eCollection 2023.
PubMed 37384665
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Search Cytomegalovirus (CMV) in Healthy Volunteers Stools Samples Selected as Potential Donor for Fecal Microbiota Transplant
- ClinicalTrials.gov ID
- NCT02694484
- Acronym / sponsor ID
- TRANSFECMV / I15033 TRANSFECMV
- Conditions
- CMV, Healthy Volunteers
- Keywords
- Cytomegalovirus, Stool sample, Healthy Volunteers, Fecal microbiota transplant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Collaborators
- University Hospital, Lille
- Study start
- Jun 2016 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 29 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | Other | Other: Blood and stool samplesFor 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood and stool samplesBlood sample at Day 1 and blood and stool sample at the next visit | Other | Healthy volunteers |
Primary outcome
Detection frequency of CMV
Time frame: 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
2 secondary outcomes
Presence of CMV in the stool and in blood.
Time frame: At day 30
Infectivity of CMV present in faecal
Time frame: At day 30
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2025.
- Results publication: PubMed 37384665Galperine T, Engelmann I, Hantz S, Postil D, Dewilde A, Deplanque D, Martin R, Labreuche J, Lazrek M, Somers S, Ribot E, Alain S. Cytomegalovirus in donors for fecal microbiota transplantation, the phantom menace? PLoS One. 2023 Jun 29;18(6):e0287847. doi: 10.1371/journal.pone.0287847. eCollection 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood and stool samples in people with CMV and Healthy Volunteers, run by University Hospital, Limoges at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection frequency of CMV (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02694484, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2025.