Fecal Microbiota Transplant for Clostridium Infections

Recruiting in Palo Alto (17 mi)

Overseen byYing Taur, MD, MPH

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Memorial Sloan Kettering Cancer Center

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?The purpose of this study is to see if fecal microbiota transplantation (FMT) will prevent the future development of CDI. This is also known as fecal bacteriotherapy or stool transplant.

Eligibility Criteria

This trial is for adults (18+) who are scheduled to receive an allogeneic hematopoietic stem cell transplantation (allo-HSCT). It's not suitable for those with severe colitis, a history of inflammatory bowel disease, or those needing long-term antibiotics that affect the gut.

Inclusion Criteria

I am 18 years old or older.

I am scheduled for a stem cell transplant from a donor.

Exclusion Criteria

I am on long-term antibiotics that affect my gut, as decided by my doctor.

I have severe bowel inflammation or a history of IBD.

Participant Groups

The study is testing whether fecal microbiota transplantation (FMT) can prevent Clostridium Difficile Infection in patients after allo-HSCT. Some participants will get FMT while others won't and will just receive routine care.

2Treatment groups

Experimental Treatment

Active Control

Group I: Fecal microbiota transplantation with pre-transplant fecesExperimental Treatment1 Intervention

Prior to transplant hospitalization, store feces for testing and possible future use. Patients undergo fecal microbiota transplantation with the subject's stored pre-transplantation feces. The post-engraftment Bacteroidetes testing, randomization, and fecal microbiota transplantation procedure should all be performed within a 28-day window, beginning on the first day of engraftment. In the event that engraftment occurs prior to day +7, the 28-day window will start on day +7. Subjects from both arms will be followed for one year after transplantation for development of CDI, which will be treated by their BMT clinicians per the standards of care at MSKCC. Subjects from both arms will also be assessed for infections and graft-versus-host disease. During the follow-up period, fecal specimens will be collected serially, if feasible, until one year post randomization and analyzed for microbial diversity and composition.

Group II: No FMT, routine managementActive Control1 Intervention

Subjects from both arms will be followed for one year after randomization for development of CDI, which will be treated by their primary BMT clinician per the standards of care at MSKCC. Subjects from both arms will also be assessed by their BMT clinicians for infections and graft-versus-host disease. During the follow-up period, fecal specimens will be collected serially if feasible until one year post randomization and analyzed for microbial diversity and composition.