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Fecal Microbiota Transplantation for the Prevention of Acute Graft Versus Host Disease in Adults Undergoing Allogeneic Hematopoietic Cell Transplantation

Sponsor
Fred Hutchinson Cancer Center (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06026371
Collaborator
(none)
138
Enrollment
1
Location
2
Arms
33
Anticipated Duration (Months)
4.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This randomized placebo-controlled double-blind phase II trial tests whether fecal microorganism (microbiota) transplantation prevents severe acute graft versus host disease in adults undergoing allogeneic hematopoietic cell transplantation (HCT). Fecal microbiota transplantation involves receiving processed fecal material orally after allogeneic HCT in order to establish a healthy gut microbiota. Gut microbiota undergoes major alterations during allogeneic HCT because of antibiotic exposures, nutritional changes, and chemotherapy administration. Establishing a healthy gut microbiota via fecal transplantation may help prevent acute graft versus host disease in patients undergoing allogeneic HCT.

Condition or Disease Intervention/Treatment Phase
  • Drug: Fecal Microbiota Transplantation Capsule
  • Drug: Placebo
 Phase 2

Detailed Description

OUTLINE: The first 12 patients are assigned to group I, remaining patients are randomized to 1 of 2 groups.

GROUP I: Patients receive fecal microbiota capsules orally (PO) once daily (QD) for 7 days starting at the time of neutrophil engraftment and discontinuation of anti-bacterial antibiotics.

GROUP II: Patients receive placebo PO QD for 7 days starting at the time of neutrophil engraftment and discontinuation of anti-bacterial antibiotics.

After completion of study intervention, patients are followed up monthly until 180 days post-allogeneic HCT.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
138 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
The first 12 patients are assigned to the treatment group, remaining patients are randomized to treatment or placebo group.The first 12 patients are assigned to the treatment group, remaining patients are randomized to treatment or placebo group.
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Investigators, treating physicians, staff, and subjects are blinded to study arm assignment (FMT vs. placebo).
Primary Purpose:
Prevention
Official Title:
Fecal Microbiota Transplantation to Prevent Acute Graft-Versus-Host Disease After Allogeneic Hematopoietic Cell Transplantation
Anticipated Study Start Date :
Jan 1, 2024
Anticipated Primary Completion Date :
Sep 30, 2026
Anticipated Study Completion Date :
Sep 30, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group I (fecal microbiota transplant)

Patients receive fecal microbiota capsules PO QD for 7 days

Drug: Fecal Microbiota Transplantation Capsule
Given PO
Other Names:
  • Fecal Microbiota Preparation Delivery Capsule
  • FMPCapDE
  • FMT Capsule DE
  • FMT Capsule Delivery
  • FMT DE Capsule

    		•
    Placebo Comparator: Group II (Placebo)

    Patients receive placebo PO QD for 7 days

    Drug: Placebo
    Given PO

    Outcome Measures

    Primary Outcome Measures

    1. Grade III-IV acute graft versus host disease (GVHD) [Up to 6 months post hematopoietic cell transplantation (HCT)]

      Based on IBMTR criteria and measured as a probability

    Secondary Outcome Measures

    1. Grade II-IV acute GVHD [Up to 6 months post HCT]

      Based on IBMTR criteria and measured as a probability

    2. Non-relapse mortality [Up to 6 months post HCT]

      Death not due to relapse/progression of the underlying hematologic disorder and measured as a probability

    3. Clostridium difficile diarrhea [Up to 6 months post HCT]

      Based on a positive stool assay in the consistent clinical setting (e.g. diarrhea) and measured as a probability

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Age >= 18

    • Signed informed consent

    • Able to take oral medications

    • Planned T-replete allogeneic hematopoietic cell transplantation for any indication. History of prior transplantation is allowed

    • Planned GVHD prophylaxis using one of the following regimens:

    • Calcineurin inhibitor (tacrolimus or cyclosporine) plus methotrexate

    • Calcineurin inhibitor (tacrolimus or cyclosporine) plus mycophenolate mofetil (MMF)

    • Sirolimus plus cyclosporine plus MMF

    • Post-transplant cyclophosphamide plus calcineurin inhibitor (with or without MMF)

    • One of the following HCT donor types:

    • Human leukocyte antigen (HLA)-matched sibling donor

    • 9/10 or 10/10 HLA-matched unrelated donor

    • HLA- haploidentical donor

    • Cord blood

    • Willing to use at least 1 accepted method of contraception until day 180 after transplant and agree to not donate eggs/sperm for 180 days after

    • Not pregnant or breast feeding

    • ELIGIBILITY CRITERIA FOR RANDOMIZATION: Resolution of all acute toxicities (other than anemia and thrombocytopenia) to Common Terminology Criteria for Adverse Events (CTCAE) grade 2 or lower

    • ELIGIBILITY CRITERIA FOR RANDOMIZATION: Ability to swallow capsules

    • ELIGIBILITY CRITERIA FOR RANDOMIZATION: No grade III-IV acute GVHD

    • ELIGIBILITY CRITERIA FOR RANDOMIZATION: No concurrent antibacterial antibiotics except to those to prevent PCP infection as standard of care.

    Exclusion Criteria:

    • Severe food allergy in the form of anaphylaxis or attributable symptoms requiring hospitalization

    • History of chronic aspiration

    • Receiving or planned to receive other experimental agents (including ex vivo T-cell depletion) to prevent GVHD

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Fred Hutch/University of Washington Cancer Consortium Seattle Washington United States 98109

    Sponsors and Collaborators

    • Fred Hutchinson Cancer Center

    Investigators

    • Principal Investigator: Armin Rashidi, Fred Hutch/University of Washington Cancer Consortium

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Fred Hutchinson Cancer Center
    ClinicalTrials.gov Identifier:
    NCT06026371
    Other Study ID Numbers:
    • RG1123691
    • NCI-2023-05599
    • RG1123691
    First Posted:
    Sep 7, 2023
    Last Update Posted:
    Sep 8, 2023
    Last Verified:
    Aug 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Graft vs Host Disease

    Study Results

    No Results Posted as of Sep 8, 2023