FMT for Steroid Resistant Gut Acute GVHD

Early Phase 1UnknownNCT04285424

Affiliated Hospital to Academy of Military Medical Sciences30 enrolled

Overview

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.

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

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

Interventions

Fecal Microbiota TransplantationBIOLOGICAL

The fecal collection produced from a single healthy donor, unrelated to the patients

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

Affiliated Hospital to Academy of Military Medical Sciences

Beijing, Beijing Municipality, China

RECRUITING

Outcomes

Primary Outcomes

Gut acute Graft-versus-Host Disease (aGvHD) response.

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

Time frame: 1 day to 7 days following FMT

Secondary Outcomes

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.

Time frame: 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.

Time frame: 1,3,5,7 days following FMT

Number of participants with infectious disorders

Evaluation of FMT activity on infectious disorder.

Time frame: 1,3,5,7 days following FMT

Number of multidrug resistant bacteria in faeces

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

Time frame: 1,3,5,7 days following FMT

Change in microbiota composition after FMT

Evaluation of microbiota composition before and after FMT

Time frame: 1,3,5,7 days months following FMT

Central Contacts

Min Min, MD

CONTACT

13426165452 minmin823@sina.com

Yan Liu, MD

CONTACT

13911798288 13911798288@163.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.