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

NCT06026371 | Active Not Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: RG1123691NCI-2023-05599FHIRB0020155
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

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.

Conditions

Hematopoietic and Lymphatic System Neoplasm; Acute Graft Versus Host Disease

Outcome Measures

Primary Outcomes (1)

• Grade III-IV acute graft versus host disease (GVHD)

  Based on International Blood and Marrow Transplantation Research (IBMTR) criteria and measured as a probability

  Up to 6 months post hematopoietic cell transplantation (HCT)

Secondary Outcomes (4)

• Grade II-IV acute GVHD

  Up to 180 days post HCT

• Non-relapse mortality

  Up to 180 days post HCT

• Clostridium difficile diarrhea

  Up to 180 days post HCT

• Chronic GVHD

  At 12 months post-HCT

Study Arms (2)

Group I (fecal microbiota transplant)

EXPERIMENTAL

Patients receive fecal microbiota capsules PO QD for 7 days

Drug: Fecal Microbiota Transplantation Capsule

Group II (Placebo)

PLACEBO COMPARATOR

Patients receive placebo PO QD for 7 days

Drug: Placebo

Interventions

Placebo DRUG

Given PO

Group II (Placebo)

Fecal Microbiota Transplantation Capsule DRUG

Given PO

Also known as: Fecal Microbiota Preparation Delivery Capsule, FMPCapDE, FMT Capsule DE, FMT Capsule Delivery, FMT DE Capsule

Group I (fecal microbiota transplant)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 or sirolimus)
• One of the following HCT donor types:
• Human leukocyte antigen (HLA)-matched sibling donor
• /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

You may not qualify if:

• Severe food allergy in the form of anaphylaxis or attributable symptoms requiring hospitalization
• History of chronic aspiration or conditions predisposing to aspiration (e.g. neuromuscular disorders)
• Receiving or planned to receive other experimental agents (including ex vivo T-cell depletion) to prevent GVHD. The use of other experimental agents is prohibited unless approved by the principal investigator (PI) of the other trial

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead

Study Sites (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

Related Publications (1)

• Reddi S, Senyshyn L, Ebadi M, Podlesny D, Minot SS, Gooley T, Kabage AJ, Hill GR, Lee SJ, Khoruts A, Rashidi A. Fecal microbiota transplantation to prevent acute graft-versus-host disease: pre-planned interim analysis of donor effect. Nat Commun. 2025 Jan 25;16(1):1034. doi: 10.1038/s41467-025-56375-y.

  PMID: 39863610 RESULT

MeSH Terms

Interventions

Fecal Microbiota Transplantation; Parturition

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics; Pregnancy; Reproduction; Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Study Officials

• Armin Rashidi

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Investigators, treating physicians, staff, and subjects are blinded to study arm assignment (FMT vs. placebo).
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The first 12 patients are assigned to the treatment group, remaining patients are randomized to treatment or placebo group.

Study Record Dates

• First Submitted: August 30, 2023
• First Posted: September 7, 2023
• Study Start: December 12, 2023
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)