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

NCT03492502 | Withdrawn

• 1 other identifier: rambam207
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Fecal Microbiota Transplantation in Graft vs. Host Disease

Keywords

Fecal microbiota transplantation; allogeneic stem cell transplantation; microbiome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Complete or partial response of GI-related GVHD after each FMT

  90 days

• Non-severe adverse events (AE)

  7 days

• Mortality

  90 days

• Change in microbiota composition after each FMT

  180 days

Study Arms (1)

Allo-SCT patients with GI related GVHD

EXPERIMENTAL

Allo-SCT patients above 18 years of age with acute steroid-resistant GI-related GVHD grade III-IV. The diagnosis of GVHD will be made on clinical grounds (in line with the major associations' recommendations) - the appearance of characteristic mucoid diarrhea within 100 days after Allo-SCT, with or without associated skin/liver involvement. In cases of atypical presentation - we will recommend biopsy or endoscopy for diagnosis. Patients suspected to have Clostridium difficille associated diarrhea will be tested for toxin (CDT). Steroid-resistant GI-related GVHD will be defined as lack of improvement (same stage) or worsening of GI symptoms after 7 days of steroid therapy (≥ 2 ml/kg of IV methylprednisolone).

Biological: Autologous Fecal Microbiota Transplantation

Interventions

Autologous Fecal Microbiota Transplantation BIOLOGICAL

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 45ᵒ 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.

Allo-SCT patients with GI related GVHD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rambam Health Care Campus: lead

Study Sites (1)

Rambam Health Care Campus

Haifa, Israel

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: March 22, 2018
• First Posted: April 10, 2018
• Study Start: August 1, 2019
• Primary Completion: March 5, 2020
• Study Completion: March 5, 2020
• Last Updated: March 11, 2020

Record last verified: 2020-03

Locations

IL (1)