FMT for Steroid Resistant Gut Acute GVHD

Stem Cell Transplant Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04285424
• Other study ID #: FMT-GVHD-7182122
• Status: Recruiting
• Phase: Early Phase 1
• Start date: March 1, 2020
• Est. completion date: March 1, 2022

Study information

• Verified date: February 2020
• Source: Affiliated Hospital to Academy of Military Medical Sciences
• Contact: Min Min, MD
• Phone: 13426165452
• Email: minmin823[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: March 1, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Graft-Versus-Host Disease
• Fecal Microbiota Transplantation
• Graft vs Host Disease
• Stem Cell Transplant Complications

Intervention

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

Locations

Country	Name	City	State
China	Affiliated Hospital to Academy of Military Medical Sciences	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Affiliated Hospital to Academy of Military Medical Sciences	The Fifth Medical Center of Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Number of participants with infectious disorders	Evaluation of FMT activity on infectious disorder.	1,3,5,7 days following FMT
Secondary	Number of multidrug resistant bacteria in faeces	Evaluation of FMT activity on multidrug-resistant bacteria (MDRB) carriage	1,3,5,7 days following FMT
Secondary	Change in microbiota composition after FMT	Evaluation of microbiota composition before and after FMT	1,3,5,7 days months following FMT