The study evaluates safety and efficacy of fecal microbiota transplantation (FMT) for the treatment of refractory graft-versus-host-disease (GVHD) of the gut. FMT might be a beneficial treatment in this clinical situation 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 have a gastrointestinal acute GVHD received a first-line standard treatment of corticosteroids. For patients who do not respond or progress after an initial response have a high mortality. Therefore, the investigation of 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 refractory GVHD of the gut. FMT might be a beneficial treatment in this clinical situation with a poor prognosis and limited therapeutic options.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
For patients who do not respond or partial respond for first time FMT treatment, a second time FMT treatment using different donor should be considered.
Efficacy of FMT in the treatment of refractory GVHD on day 7
Participants will be evaluated on days 7 following FMT. The volume and frequency of daily diarrhoea will be continuous observed and recorded in 7 days.
Time frame: 7 days following FMT
Efficacy of FMT in the treatment of refractory GVHD on day 28
Participants will be evaluated on days 28 following FMT. The volume and frequency of daily diarrhoea will be continuous observed and recorded in 28 days.
Time frame: 28 days following FMT
Treatment-related AEs and SAEs
The overall safety of the study will be evaluated with the incidence of all Adverse Events (AEs) and Serious Adverse Events (SAEs) within 28 days following FMT. The relationship of any kind AEs and FMT will be seriously evaluated. Non-serious AEs include: dyspepsia, abdominal pain, nausea, vomiting, diarrhea, constipation, fever, inhalation without mechanical ventilation, etc. SAEs include: death, sepsis, aspiration pneumonia, gastrointestinal hemorrhage, septic shock, etc.
Time frame: up to 28 days following FMT
GVHD severity
Patients will be evaluated on days 7 and 28 following transplantation for severity of GVHD. GVHD severity is graded by the International Bone Marrow Transplant Registry Severity Index grading system.
Time frame: up to 28 days following FMT
Implantation rate
The data will be compared with patients who had not participated in clinical trials.
Time frame: through study completion, an average of 6 months
Survival rate
The data will be compared with patients who had not participated in clinical trials.
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Time frame: through study completion, an average of 6 months
Change in biomarkers
Change in levels of albumin and C-reactive protein between days 0 and days 28 will serve as a secondary endpoint.
Time frame: up to 28 days following FMT
Number of patients with infectious disorders
Evaluation of FMT activity on infectious disorder.
Time frame: through study completion, an average of 6 months
Quality of Life
The quality of life of patients will be measured using a standardized quality of life questionnaire (EORTC QLQ-C30) prior to transplantation and on days 7, 14, 21, 28 and 180 following transplantation.
Time frame: up to 6 months following FMT