Autologous Fecal Microbiota Transplantation (Auto-FMT) for Prophylaxis of Clostridium Difficile Infection in Recipients of Allogeneic Hematopoietic Stem Cell Transplantation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2026-10-31

Brief Summary

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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.

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Detailed Description

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This is a randomized, open-label, controlled study designed to assess the efficacy of autologous fecal microbiota transplantation (auto-FMT) for prevention of Clostridium difficile infection (CDI) in patients who have undergone allogeneic hematopoietic stem cell transplantation (allo-HSCT). Patients will be enrolled prior to allo-HSCT; feces will be collected and stored from all participating subjects prior to the initiation of conditioning regimens, analyzed by deep 16S rRNA gene sequencing, and tested by assay for intestinal pathogens including Clostridium difficile. Later in the course of transplantation, following engraftment (defined as the first day of three consecutive days, that the absolute blood neutrophil count is at above f 500 mm3), subjects will undergo fecal testing for presence of Bacteroidetes by 16S PCR. Subjects will be eligible for study if they have a microbiologically diverse pre-transplant colonic microbiota, and if the post-engraftment specimen contains Bacteroidetes at a prevalence equal to or below (0.1%)

Conditions

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Allogeneic Hematopoietic Stem Cell

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Fecal microbiota transplantation with pre-transplant feces

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 Type EXPERIMENTAL

fecal microbiota transplantation (FMT)

Intervention Type BIOLOGICAL

No FMT, routine management

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.

Group Type ACTIVE_COMPARATOR

No fecal microbiota transplantation (FMT), routine management

Intervention Type OTHER

Interventions

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fecal microbiota transplantation (FMT)

Intervention Type BIOLOGICAL

No fecal microbiota transplantation (FMT), routine management

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Planned to undergo allo-HSCT
* Age ≥ 18 years

Exclusion Criteria

* As determined by the study investigators or consenting professionals, prolonged antibiotic treatment, as prevention or suppression of an ongoing infection, where treatment involves gut-perturbing antianaerobic antibiotics
* Has severe colitis of any etiology or a history of inflammatory bowel disease (IBD).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No