Comparison of MTC01 vs FMT for the Treatment of Recurrent Clostridioides Difficile Infection
Icahn School of Medicine at Mount Sinai
Summary
Investigating four different treatment of MTC or FMT
Description
The purpose of this research study is to compare two different treatments for patients with recurrent Clostridiodies difficile infections: MTC01 vs fecal microbiota transplantation (FMT). FMT is the transfer of bacteria from a healthy donor's colon to a recipient's colon. To do this, stool from a healthy donor is blended with salt water and made into a liquid solution rich in bacteria. This solution is sprayed into the recipient's colon during a colonoscopy. This treatment is now considered standard medical care for recurrent Clostridioides difficile infections. One FMT dose contains the enti…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Ages eligible for study: 18 years and older * Able and willing to provide written informed consent * History of recurrent CDI defined as 2 episodes of CDI occurring within the previous 6 months (inclusive of the current episode) * Subjects with a qualifying recurrent CDI episode, defined as: * History of diarrhea (\>=3 unformed stools per day for 2 or more consecutive days that is clinically consistent with CDI * Documented positive stool test by local laboratory for toxigenic C. difficile (toxin EIA or PCR-based testing) for the current CDI episode within 60 days p…
Interventions
- DrugMTC 01
Slurry to be administered via colonoscopy
- DrugFecal Microbiota Transplantation (FMT)
Stool from a healthy donor is blended with salt water and made into a liquid solution rich in bacteria. This solution is sprayed into the recipient's colon during a colonoscopy
Location
- Icahn School of Medicine at Mount SinaiNew York, New York