Autologous Fecal Microbiota Transplantation for Patients With Acute Graft-versus-Host Disease

Fecal Microbiota Transplantation in Graft vs. Host Disease Clinical Trial

Official title:

Autologous Fecal Microbiota Transplantation for Patients With Acute Graft-versus-Host Disease

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03492502
• Other study ID #: rambam207
• Status: Withdrawn
• Phase: N/A
• Start date: August 1, 2019
• Est. completion date: March 5, 2020

Study information

• Verified date: March 2020
• Source: Rambam Health Care Campus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 5, 2020
• Est. primary completion date: March 5, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fecal Microbiota Transplantation in Graft vs. Host Disease
• Graft vs Host Disease

Intervention

Biological:
• Autologous Fecal Microbiota Transplantation
Consenting allo- SCT patients with acute steroid-resistant GI-related GVHD grade III-IV will receive autologous FMT by nasogastric tube. Standardized stool suspension will be given once a day for two consecutive days.In order to prevent aspiration, patients will be kept in a 45? upright position for four hours. Participants will fast the night before and be treated with proton pump inhibitors prior to each FMT. In cases where complete response was not obtained within 7 days after autologous FMT, patients may be eligible for another trail of autologous FMT or to switch to other pharmacological interventions. Stool samples will be collected before and after the intervention for microbial analyses.

Locations

Country	Name	City	State
Israel	Rambam Health Care Campus	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Development of severe adverse events (SAEs) related to autologous FMT	Development of SAEs related to autologous FMT within 7 days after the intervention. SAEs include mortality, bacteremia, and radiological-proven aspiration pneumonia requiring mechanical ventilation.	7 days
Secondary	Complete or partial response of GI-related GVHD after each FMT	Patients will be evaluated 90 days following FMT for symptoms severity and response. Response is defined as: Complete response - resolution of all GI symptoms; Partial response - decrease of severity of GI-related GVHD by at least one stage or ability to taper steroids to <0.5 mg/kg; No response - progression of symptoms or no change in GI symptoms	90 days
Secondary	Non-severe adverse events (AE)	Non-severe adverse events including dyspepsia, abdominal pain, nausea, vomiting, diarrhea, constipation, fever, or aspiration not requiring mechanical ventilation. Each AE will be graded.	7 days
Secondary	Mortality		90 days
Secondary	Change in microbiota composition after each FMT		180 days