Clinical trial NCT03492502: Autologous Fecal Microbiota Transplantation for Patients With Acute Graft-versus-Host Disease
Official title: Autologous Fecal Microbiota Transplantation for Patients With Acute Graft-versus-Host Disease
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Fecal Microbiota Transplantation in Graft vs. Host Disease
Keywords: Fecal microbiota transplantation
allogeneic stem cell transplantation
microbiome
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2018-04-10
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study aims to assess the safety and efficacy of autologous fecal microbiota transplantation (FMT) in gastrointestinal (GI) related graft-versus-host disease (GVHD). Stool for FMT will be prepared from pre-allogeneic stem cell transplantation (Allo-SCT) period. This strategy might offer a novel and safe therapeutic approach for these patients, who suffer from high disease related morbidity and mortality and are refractory to multiple treatments.

Detailed description: All candidates for Allo-SCT at BMT unit in RHCC will be screened for study inclusion and exclusion criteria. Seven to fourteen days prior to Allo-SCT (before initiation of SCT related antimicrobials), all consenting patients will supply stool sample (first stool sample), which will serve as the autologous FMT sample, and clinical data will be collected. Patients who will develop GI related GVHD will be asked to supply another stool sample 7±2 days after the appearance of GVHD related symptoms (second stool sample). Clinical and laboratory data will be collected. Another stool sample will be collected 7-14 following autologous FMT (third stool sample), and clinical data and outcome will be documented. Day 1 of the study will be defined as day of Allo-SCT, and follow up period is 6 months. Complementary data will be collected from the electronic medical records.

Eligibility criteria: Inclusion Criteria:

\* Allo-SCT patients above 18 years of age with acute steroid-resistant GI-related GVHD grade III-IV.

Exclusion Criteria:

* Prior inclusion to an interventional study
* Pregnant or lactating women
* Previous Allo-SCT
* Known multi-drug resistance carriage prior to stool collection
* Severe colitis of any etiology or a history of inflammatory bowel disease (IBD)
* Uncontrolled infection (hemodynamic instability, ongoing fever or bacteremia within 3 days after antibiotics administration)
* Active GI bleeding
* Absolute neutrophil count \< 500 cells/microL
* Patients who cannot give informed consent

Primary outcomes:
measure: Development of severe adverse events (SAEs) related to autologous FMT
timeFrame: 7 days
Secondary outcomes:
measure: Complete or partial response of GI-related GVHD after each FMT
timeFrame: 90 days
measure: Non-severe adverse events (AE)
timeFrame: 7 days
measure: Mortality
timeFrame: 90 days
measure: Change in microbiota composition after each FMT
timeFrame: 180 days
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Health Care Campus
Study officials:
References: