Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06311006
Status:
RECRUITING
Last Update Posted:
2024-03-15
First Post:
2024-02-28
Brief Title:
Safety Registry of a Fecal Microbiota Transplant Cohort
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Safety Registry of a Fecal Microbiota Transplant Cohort COSMIC-FMT
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COSMIC-FMT
Brief Summary:
Clostridium difficile infection CDI is a major cause of infectious diarrhea and the most important cause of nosocomial diarrhea Recurrent forms are a major problem with this infection The use of fecal microbiota transplantation FMT FMT appears in the most recent European and North American recommendations
There is no cohort or multicenter registry in France prospectively collecting FMTs the methods used their efficacy and side effects Likewise there is no prospective collection focused on the cohort of stool donors A large national cohort of patients who have undergone FMT as part of routine care as well as donors is essential for evaluating the safety of FMT
There is no cohort or multicenter registry in France prospectively collecting FMTs the methods used their efficacy and side effects Likewise there is no prospective collection focused on the cohort of stool donors A large national cohort of patients who have undergone FMT as part of routine care as well as donors is essential for evaluating the safety of FMT
Detailed Description:
Clostridium difficile infection CDI is a major cause of infectious diarrhea and the most important cause of nosocomial diarrhea For 20 years the incidence of CDI has continued to increase In addition the severity of infections is also increasing mortality 5 in 1990 against 138 in 2003 complications 6 in 1990 against 18 in 2003
Recurrent forms represent a major problem of this infection Indeed after a first episode the risk of a first recurrence is around 15 to 25 and this risk then increases with each recurrence reaching 45 then 65 after a first and second recurrence respectively These Recurrent forms pose a real therapeutic problem causing significant morbidity repeated hospitalizations time off work etc and substantial mortality Patients with CDI are 25 times more likely to die within 30 days of infection than uninfected patients regardless of age or comorbidities The mortality rate is also higher in patients with a recurrent form than in those with a single episode Furthermore the antibiotics usually used are only marginally effective in cases of recurrent CDI
Numerous studies including two randomized trials have shown that fecal microbiota transplantation FMT is superior to antibiotic therapy in reducing subsequent recurrences the use of FMT in this indication appears in the most recent European and North American recommendations
Cosmic-FMT cohort aims to be as representative as possible of the population of patients having FMT for CDI in the context of care
Recurrent forms represent a major problem of this infection Indeed after a first episode the risk of a first recurrence is around 15 to 25 and this risk then increases with each recurrence reaching 45 then 65 after a first and second recurrence respectively These Recurrent forms pose a real therapeutic problem causing significant morbidity repeated hospitalizations time off work etc and substantial mortality Patients with CDI are 25 times more likely to die within 30 days of infection than uninfected patients regardless of age or comorbidities The mortality rate is also higher in patients with a recurrent form than in those with a single episode Furthermore the antibiotics usually used are only marginally effective in cases of recurrent CDI
Numerous studies including two randomized trials have shown that fecal microbiota transplantation FMT is superior to antibiotic therapy in reducing subsequent recurrences the use of FMT in this indication appears in the most recent European and North American recommendations
Cosmic-FMT cohort aims to be as representative as possible of the population of patients having FMT for CDI in the context of care
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2019-A02579-48 | OTHER | ANSM | None |