FMT for Steroid Resistant Gut Acute GVHD

Fecal Microbiota Transplantation for Treatment of Steroid Resistant Acute Graft Versus Host Disease of the Gut

The study aims to evaluate the safety and efficacy of fecal microbiota transplantation (FMT) for the treatment of steroid resistant graft-versus-host-disease (GVHD) of the gut. This strategy might offer a safe and effective therapeutic approach for these patients with a poor prognosis and limited therapeutic options.

Study Overview

• Status: Unknown
• Conditions: Stem Cell Transplant Complications; Fecal Microbiota Transplantation; Acute Graft-Versus-Host Disease
• Intervention / Treatment: Biological: Fecal Microbiota Transplantation

Detailed Description

Graft-versus-host-disease (GVHD) is a major complication after hematopoietic stem cell transplantation (HSCT). Gut is the most vulnerable target organ of acute GVHD. Patients who develope the acute gut GVHD and do not respond to the first line therapy with steroids have a high mortality. The investigation of safe and effective second line therapy for these patients are in need. The study evaluates safety and efficacy of fecal microbiota transplantation (FMT) for the treatment of streoid resistant GVHD of the gut. Stool for FMT will be prepared from the healthy donor.This strategy might offer a safe and effective therapeutic approach for these acute steroid resistant gut GVHD patients.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Min Min, MD; Phone Number: 13426165452; Email: minmin823@sina.com
• Study Contact Backup: Name: Yan Liu, MD; Phone Number: 13911798288; Email: 13911798288@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Recruiting
      • Affiliated Hospital to Academy of Military Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 1. Adults(ages are elder than 18 years and younger than 75 years) who developed gut acute Graft-versus-Host Disease(aGVHD) after allogeneic hematopoietic stem cell transplantation(HSCT) and were resistant to a first line therapy with steroids.

  2. patients who were diagnosed as Stage 3 or 4 Gastro-intestinal Acute Graft-versus-Host(GI-aGVHD) with the symptoms such as diarrhea or abdominal pain.

  3. Participants who accepted the FMT treatment. 4. Signature of informed and written consent by the subject.

Exclusion Criteria:

• 1. patients who were diagnosed as Stage 1 or 2 Gastro-intestinal Acute Graft-versus-Host(GI-aGVHD) 2. patients with unstable vital signs or severe cardiac and pulmonary disorder. 3. patients who were failure to cooperate endoscopy examination. 4. patients who were younger than 18 years or pregnant. 5. patients who were poor compliance to FMT treatment. 6. patients who were not able to give informed consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: HSCT patients with acute steroid-resistant GI-related GVHD; Patients will receive 500ml fecal microbiota which were sprayed evenly on the entire colon through colonscopy or duodenal nutrition tube injection which collected from one unrelated healthy donors. Patients receiving FMT treatment will be followed for at least 1,3,5,7 days.Stool, blood and colonic mucosa samples will be serially collected and tested (before pre-treatment, 1,3,5,7 days after FMT).

Biological: Fecal Microbiota Transplantation; The fecal collection produced from a single healthy donor, unrelated to the patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gut acute Graft-versus-Host Disease (aGvHD) response.	Participants will be evaluated within 7 days following transplantation for response to therapy.	1 day to 7 days following FMT

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Non-serious adverse events	Participants will be evaluated for non-serious adverse events relating to FMT within 7 days following transplantation. Non-serious adverse events are defined as diarrhea, nausea and vomiting, fatigue and malaise, headache, and distension/bloating/abdominal discomfort/pain.	1,3,5,7 days following FMTs
aGvHD severity	Number of participants will be evaluated on 1，3，5, 7 days following transplantation for severity of aGvHD.	1,3,5,7 days following FMT
Number of participants with infectious disorders	Evaluation of FMT activity on infectious disorder.	1,3,5,7 days following FMT
Number of multidrug resistant bacteria in faeces	Evaluation of FMT activity on multidrug-resistant bacteria (MDRB) carriage	1,3,5,7 days following FMT
Change in microbiota composition after FMT	Evaluation of microbiota composition before and after FMT	1,3,5,7 days months following FMT

Collaborators and Investigators

• Sponsor: Affiliated Hospital to Academy of Military Medical Sciences
• Collaborators: Beijing 302 Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2020
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): March 1, 2022

Study Registration Dates

• First Submitted: February 20, 2020
• First Submitted That Met QC Criteria: February 25, 2020
• First Posted (Actual): February 26, 2020

Study Record Updates

• Last Update Posted (Actual): March 2, 2020
• Last Update Submitted That Met QC Criteria: February 27, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Graft vs Host Disease
• Other Study ID Numbers: FMT-GVHD-7182122

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No