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| Name | Class |
|---|---|
| University Hospital, Lille | OTHER |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood and stool samples | Other | Blood sample at Day 1 and blood and stool sample at the next visit |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Infectivity of CMV present in faecal |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre de biologie pathologie / Laboratoire de virologie | Lille | 59037 | France | |||
| Cic 1403-Crb Inserm-Chu |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37384665 | Result | 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. |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Evaluation of the infectivity of CMV present in faecal
| At day 30 |
| Lille |
| 59037 |
| France |
| Service des Maladies Infectieuses | Lille | 59037 | France |
| Cic - Inserm - 1435 | Limoges | 87042 | France |
| Service de Bactériologie-Virologie-Hygiène/CNR des Cytomégalovirus | Limoges | 87042 | France |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |