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

Primary Purpose

Allogeneic Hematopoietic Stem Cell

Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
fecal microbiota transplantation (FMT)
No fecal microbiota transplantation (FMT), routine management
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Allogeneic Hematopoietic Stem Cell focused on measuring Recipients, Transplantation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Memorial Sloan Kettering Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Fecal microbiota transplantation with pre-transplant feces

No FMT, routine management

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Clostridium difficile infection (CDI)
CDI is defined as diarrheal stool (unformed stool conforming to the shape of a specimen container), and a positive test for toxin-producing C. difficile (either by toxin B gene PCR or cytotoxicity assay).

Secondary Outcome Measures

Full Information

First Posted
October 15, 2014
Last Updated
July 26, 2023
Sponsor
Memorial Sloan Kettering Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT02269150
Brief Title
Autologous Fecal Microbiota Transplantation (Auto-FMT) for Prophylaxis of Clostridium Difficile Infection in Recipients of Allogeneic Hematopoietic Stem Cell Transplantation
Official Title
A Randomized Controlled Trial of Autologous Fecal Microbiota Transplantation (Auto-FMT) for Prophylaxis of Clostridium Difficile Infection in Recipients of Allogeneic Hematopoietic Stem Cell Transplantation
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 2014 (Actual)
Primary Completion Date
October 2025 (Anticipated)
Study Completion Date
October 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center

4. Oversight

5. Study Description

Brief Summary
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.
Detailed Description
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%)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allogeneic Hematopoietic Stem Cell
Keywords
Recipients, Transplantation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fecal microbiota transplantation with pre-transplant feces
Arm Type
Experimental
Arm Description
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.
Arm Title
No FMT, routine management
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
fecal microbiota transplantation (FMT)
Intervention Type
Other
Intervention Name(s)
No fecal microbiota transplantation (FMT), routine management
Primary Outcome Measure Information:
Title
Clostridium difficile infection (CDI)
Description
CDI is defined as diarrheal stool (unformed stool conforming to the shape of a specimen container), and a positive test for toxin-producing C. difficile (either by toxin B gene PCR or cytotoxicity assay).
Time Frame
up to 1 year following randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ying Taur, MD, MPH
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26590773
Citation
Taur Y, Jenq RR, Ubeda C, van den Brink M, Pamer EG. Role of intestinal microbiota in transplantation outcomes. Best Pract Res Clin Haematol. 2015 Jun-Sep;28(2-3):155-61. doi: 10.1016/j.beha.2015.10.013. Epub 2015 Oct 22.
Results Reference
derived
Links:
URL
http://www.mskcc.org/
Description
Memorial Sloan Kettering Cancer Center

Learn more about this trial

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

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