Safety Registry of a Fecal Microbiota Transplant Cohort
ConditionClostridium Difficile Infections
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Adult patient with an indication for FMT for CDI (severe refractory CDI, recurrent CDI);
Informed written consent
Adult (18 years or older)
Informed Written consent
Disqualifiers
insufficient level of understanding of written and spoken French language
Trial population
Patient with an indication for fecal microbiota transplantation as part of the treatment for Clostridium difficile infection
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
305 Participants
are grouped into 2 trial groupsGroup A: Patients
Group B: Stool donor
Trial outcomes
Primary outcomes
1
Proportion of hospitalizations attributable to FMT
Time frame
Week 10 and 3 years after FMTSecondary outcomes
1
Proportion of Clostridium difficile relapses
In the short term: rate of occurrence of at least one recurrence of CDI within 10 weeks after FMT; In the medium term: rate of occurrence of at least one recurrence of CDI \> 10 weeks and ≤ 3 years after FMT.
Time frame
10 weeks after FMT, and 3 years2
Proportion of relapse
The strains will be characterized in each center according to local methods.
Time frame
Week 10 and 3 years3
Proportion of reinfections
The strains will be characterized in each center according to local methods.
Time frame
Week 10 and 3 years4
Efficacy of FMT in CDI (defined as free from relapse) at 10 weeks and 3 years according to clinical characteristics of donors
Time frame
at 10 weeks and 3 yearsSponsors and contacts
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Source ClinicalTrials.gov