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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03214289
• Date of registration: 29/06/2017
• Prospective Registration: Yes
• Primary sponsor: Sheba Medical Center
• Public title: Fecal Microbiota Transplantation for Steroid Resistant and Steroid Dependent Gut Acute Graft Versus Host Disease
• Scientific title: Fecal Microbiota Transplantation for Treatment of Steroid Resistant and Steroid Dependent Gut Acute Graft Versus Host Disease- a Pilot Study
• Date of first enrolment: July 12, 2017
• Target sample size: 4
• Recruitment status: Unknown status
• URL: https://clinicaltrials.gov/show/NCT03214289
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

Israel

Contacts

• Name: Roni Shouval, MD
• Affiliation: Sheba Medical Center

• Name: Roni Shouval, MD

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Stem Cell Transplant Complications

Fecal Microbiota Transplantation

Graft Versus Host Disease, Acute

Intervention(s)

Biological: Fecal Microbiota Transplantation

Primary Outcome(s)

Serious adverse events [Time Frame: 28 days following FMT.]

Secondary Outcome(s)

Non-serious adverse events [Time Frame: 28 days following FMT.]

Reduction in the dose of steroids. [Time Frame: up to 28 days following FMT.]

aGvHD severity [Time Frame: up to 28 days following FMT.]

Gut acute Graft-versus-Host Disease (aGvHD) response. [Time Frame: up to 28 days following FMT.]

Secondary ID(s)

3822-16-SMC

Source(s) of Monetary Support

Please refer to primary and secondary sponsors