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Fecal Microbiota Transplantation

Fecal Microbiota Transplant for Clostridium Infections

Phase 2

Waitlist Available

Led By Ying Taur, MD, MPH

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥ 18 years

Planned to undergo allo-HSCT

Must not have

Severe colitis of any etiology or a history of inflammatory bowel disease (IBD)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year following randomization

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether fecal microbiota transplantation (FMT) can prevent the future development of Clostridium difficile infection (CDI).

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects from FMT may include discomfort at the administration site, bloating, diarrhea, nausea or infection. The exact side effects will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have severe bowel inflammation or a history of IBD.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year following randomization

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year following randomization

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year following randomization for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Clostridium difficile infection (CDI)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 3Eligibility criteria met