Fecal Microbiota Transplantation for Steroid Resistant and Steroid Dependent Gut Acute Graft Versus Host Disease

NCT03214289 | Unknown Phase 1

• 1 other identifier: 3822-16-SMC
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators hypothesize that perturbations in the intestinal microbiota following allogeneic hematopoietic stem cell transplantation (HSCT) are essential for the development and propagation of acute graft-versus-host disease. Therefore, modification of HSCT recipients' gut microbiota using fecal transplantation from a healthy donor could be used to treat gut acute GVHD. The study evaluates safety and feasibility of fecal microbiota transplantation with frozen capsules from healthy donors for the treatment of steroid resistant or steroid dependent acute graft-versus-host disease of the gut.

Conditions

Stem Cell Transplant Complications; Graft Versus Host Disease, Acute; Fecal Microbiota Transplantation

Keywords

Fecal Microbiota Transplantation; Intestinal Acute Graft Versus Host Disease; Hematopoietic Stem Cell Transplantation

Outcome Measures

Primary Outcomes (1)

• Serious adverse events

  Participants will be evaluated for serious adverse events (SAEs) relating to FMT occurring within 28 days following transplantation. SAEs are defined as any adverse experience occurring during or after FMT that results in any of the following outcomes: death, life-threatening experience, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity or an important medical event events

  28 days following FMT.

Secondary Outcomes (4)

• Non-serious adverse events

  28 days following FMT.

• Gut acute Graft-versus-Host Disease (aGvHD) response.

  up to 28 days following FMT.

• aGvHD severity

  up to 28 days following FMT.

• Reduction in the dose of steroids.

  up to 28 days following FMT.

Study Arms (1)

Fecal Microbiota Transplantation (FMT)

EXPERIMENTAL

Participants will receive a single dose of oral FMT, which is 15 capsules per day for 2 consecutive days (total of 30 capsules). All capsules administered to a participant are from the same unrelated donor. Participants will be asked to fast for 4 hours prior to and 1 hour following capsule intake. Participants will be asked to drink at least 360cc of water during administration. Treatment will be administered on an inpatient basis. In patients with no/partial response, the FMT may be repeated from the same or a different donor. Subjects receiving any amount of the FMT capsules will be followed for at least 6 months.Stool and blood samples will be serially collected.

Biological: Fecal Microbiota Transplantation

Interventions

Fecal Microbiota Transplantation BIOLOGICAL

Thirty fecal microbiota capsules produced from a single healthy donor, unrelated to the participant.

Fecal Microbiota Transplantation (FMT)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults (ages 18 to 75 years) who underwent allogeneic hematopoietic stem cell transplantation (HSCT) and developed gut acute Graft-versus-Host Disease (aGvHD).
• Participants have steroid-resistant or steroid-dependent gut aGvHD.
• Steroid resistant gut aGvHD is defined as cases in which gastrointestinal symptoms do not improve within 7 days after initial steroid therapy (≥1 mg/kg of methylprednisolone) or clear progression after 5 days.)
• Steroid-dependent gut aGVHD is defined as cases in which reduction of steroid dose was not possible due to exacerbation of gastrointestinal symptoms.
• Participants may have undergone allogeneic HSCT for any diagnosis at any time prior to developing aGvHD, and are not restricted to any specific conditioning regimen or by the subsequent administration of donor lymphocyte infusion.
• Participants should be able to give informed consent.

You may not qualify if:

• Participants may not have gut aGvHD which permits the tapering of steroid dose.
• Participants may not have ongoing, uncontrolled infection (i.e. unresolved bacteremia, uncontrolled CMV infection).
• Participants may not have ongoing enteritis primarily caused by enteropathy other than gut GvHD, excluding resistant clostridium difficile infection.
• Participants may not have acute neutrophil count \< 500 cells/µL.
• Participants may not have toxic megacolon
• Participants may not have active gastrointestinal bleeding.
• Participants may not be pregnant or lactating.
• Participants may not be unable to swallow pills.

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

Chaim Sheba Medical Center

Ramat Gan, Israel

RECRUITING

MeSH Terms

Conditions

Graft vs Host Disease

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Roni Shouval, MD

  Sheba Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Roni Shouval, MD

CONTACT

972-3-5305830; roni.shoval@sheba.health.gov.il

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Hematology and BMT Division

Study Record Dates

• First Submitted: June 29, 2017
• First Posted: July 11, 2017
• Study Start: July 12, 2017
• Primary Completion: July 20, 2019
• Study Completion: December 20, 2019
• Last Updated: April 9, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)