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

NCT ID: NCT03214289

Last Updated: 2018-04-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-12
• Study Completion Date: 2019-12-20

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Fecal Microbiota Transplantation (FMT)

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.

Group Type: EXPERIMENTAL

Fecal Microbiota Transplantation

Intervention Type: BIOLOGICAL

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

Interventions

Fecal Microbiota Transplantation

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sheba Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Dr. Shouval Roni

Principal Investigator, Hematology and BMT Division

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Roni Shouval, MD

Role: PRINCIPAL_INVESTIGATOR

Sheba Medical Center

Locations

Chaim Sheba Medical Center

Ramat Gan, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Roni Shouval, MD

Role: CONTACT

roni.shoval@sheba.health.gov.il

972-3-5305830

Other Identifiers

3822-16-SMC

Identifier Type: OTHER

Identifier Source: secondary_id

3822-16-SMC

Identifier Type: -

Identifier Source: org_study_id