Clinical trial NCT03214289: Fecal Microbiota Transplantation for Steroid Resistant and Steroid Dependent Gut Acute Graft Versus Host Disease
Official title: Fecal Microbiota Transplantation for Treatment of Steroid Resistant and Steroid Dependent Gut Acute Graft Versus Host Disease- a Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
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
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2017-07-11
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Serious adverse events
timeFrame: 28 days following FMT.
Secondary outcomes:
measure: Non-serious adverse events
timeFrame: 28 days following FMT.
measure: Gut acute Graft-versus-Host Disease (aGvHD) response.
timeFrame: up to 28 days following FMT.
measure: aGvHD severity
timeFrame: up to 28 days following FMT.
measure: Reduction in the dose of steroids.
timeFrame: up to 28 days following FMT.
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Chaim Sheba Medical Center
Study officials:
affiliation: Sheba Medical Center
name: Roni Shouval, MD
role: PRINCIPAL_INVESTIGATOR
References: