FMT for Steroid Resistant Gut Acute GVHD

• Sponsor: Affiliated Hospital to Academy of Military Medical Sciences (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04285424
• Collaborator: Beijing 302 Hospital (Other)
• Enrollment: 30
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 24
• Patients Per Site Per Month: 1.3

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Stem Cell Transplant Complications; Acute Graft-Versus-Host Disease; Fecal Microbiota Transplantation	Biological: Fecal Microbiota Transplantation	Early Phase 1

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Fecal Microbiota Transplantation for Treatment of Steroid Resistant Acute Graft Versus Host Disease of the Gut
• Anticipated Study Start Date: Mar 1, 2020
• Anticipated Primary Completion Date: Dec 31, 2021
• Anticipated Study Completion Date: Mar 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Gut acute Graft-versus-Host Disease (aGvHD) response. [1 day to 7 days following FMT]

   Participants will be evaluated within 7 days following transplantation for response to therapy.

Secondary Outcome Measures

1. Non-serious adverse events [1,3,5,7 days following FMTs]

   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.

2. aGvHD severity [1,3,5,7 days following FMT]

   Number of participants will be evaluated on 1，3，5, 7 days following transplantation for severity of aGvHD.

3. Number of participants with infectious disorders [1,3,5,7 days following FMT]

   Evaluation of FMT activity on infectious disorder.

4. Number of multidrug resistant bacteria in faeces [1,3,5,7 days following FMT]

   Evaluation of FMT activity on multidrug-resistant bacteria (MDRB) carriage

5. Change in microbiota composition after FMT [1,3,5,7 days months following FMT]

   Evaluation of microbiota composition before and after FMT

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

1. 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.

2. 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Affiliated Hospital to Academy of Military Medical Sciences	Beijing	Beijing	China

Sponsors and Collaborators

• Affiliated Hospital to Academy of Military Medical Sciences
• Beijing 302 Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Affiliated Hospital to Academy of Military Medical Sciences
• ClinicalTrials.gov Identifier: NCT04285424
• Other Study ID Numbers: FMT-GVHD-7182122
• First Posted: Feb 26, 2020
• Last Update Posted: Mar 2, 2020
• Last Verified: Feb 1, 2020

• 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
• Additional relevant MeSH terms: Graft vs Host Disease

Study Results

No Results Posted as of Mar 2, 2020