Safety Registry of a Fecal Microbiota Transplant Cohort

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Mar 7, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the safety and effectiveness of fecal microbiota transplantation (FMT) for patients suffering from Clostridium difficile infections (CDI), which can cause severe diarrhea and often comes back after treatment. The trial aims to gather important information about how FMT is performed, its success rates, and any side effects it may cause. Currently, there isn't a comprehensive database in France that tracks these details, so this study hopes to fill that gap by looking at both patients receiving FMT and the donors providing the stool samples.

To participate in the trial, patients need to be adults who have been recommended for FMT due to severe or recurring CDI and must provide written consent. Similarly, stool donors must also be adults and agree to participate. One important point to note is that participants must be able to understand written and spoken French, as this is necessary for effective communication throughout the study. Overall, this trial will help improve our understanding of FMT and its potential benefits for patients with CDI.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• Patients :
• • Adult patient with an indication for FMT for CDI (severe refractory CDI, recurrent CDI);
• • Informed written consent
• Donors:
• • Adult (18 years or older)
• • Informed Written consent
• Exclusion Criteria:
• • insufficient level of understanding of written and spoken French language