Outcomes and Data Collection for Fecal Microbiota Transplantation for the Treatment of Recurrent Clostridium Difficile

Launched by KRUNAL PATEL · Jun 7, 2018

Keywords

ClinConnect Summary

This clinical trial is studying a procedure called fecal microbiota transplantation (FMT) to see if it can help people who keep getting sick from a type of infection called Clostridium difficile, or C. diff for short. The trial involves taking a stool sample from a healthy donor, like a family member or close friend, and placing it directly into the colon of a patient through a procedure called colonoscopy. The aim is to restore the healthy bacteria in the colon, which may help prevent the C. diff infection from returning after treatment.

To be eligible for this trial, participants should have experienced two or more episodes of C. diff infection, which means they had positive test results and appropriate symptoms like severe diarrhea within a certain time frame. They should also have tried standard treatments that didn’t work. However, individuals under 16 years old or those with certain severe conditions affecting their colon cannot join. If someone participates, they can expect to have the stool transplant procedure and be monitored to see how well it works in preventing future infections. This trial is currently looking for volunteers to help find out if this approach is effective.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Two or more recurrences of C. difficile infection (CDI) with recurrence defined as a positive test result, e.g. Polymerase Chain Reaction (PCR) test and with appropriate symptoms within 2-8 weeks of last positive result, provided that symptoms from earlier episode resolved with or without therapy.
• • Failed standard therapy with oral metronidazole and/or oral vancomycin
• • One or more episodes of severe CDI resulting in hospitalization and not responding to standard antibiotic therapy. Hospitalization for CDI occurs in the setting of severe diarrhea, abdominal pain and signs of systemic toxicity
• Exclusion criteria:
• • Age \<16 years old
• • patients with acute severe colonic dilation at risk for colonic perforation