Acute Graft-Versus-Host Disease, Fecal Microbiota Transplantation, Stem Cell Transplant Complications
Conditions
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.
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.
Interventions
BIOLOGICALFecal Microbiota Transplantation
The fecal collection produced from a single healthy donor, unrelated to the patients
Sponsors
Beijing 302 Hospital
Affiliated Hospital to Academy of Military Medical Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Change in microbiota composition after FMT | 1,3,5,7 days months following FMT | Evaluation of microbiota composition before and after FMT |
| 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. |
| 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. |
| Number of participants with infectious disorders | 1,3,5,7 days following FMT | Evaluation of FMT activity on infectious disorder. |
| Number of multidrug resistant bacteria in faeces | 1,3,5,7 days following FMT | Evaluation of FMT activity on multidrug-resistant bacteria (MDRB) carriage |
Countries
China
Contacts
Primary ContactMin Min, MD
Backup ContactYan Liu, MD
Outcome results
None listed