Clinical trial
Fecal Microbiota Transplantation for the Treatment of Steroid Resistant/Dependent Acute Gastrointestinal Graft Versus Host Disease
Name
SHSYXY-FMT-GVHD-2018002
Description
The purpose of this study is to evaluate the efficacy and safety of fecal microbiome transplantation in patients with steroid resistant/dependent acute gastrointestinal graft-versus-host disease (GVHD). The patient will cease antibiotics treatment 1 day before FMT, and stop taking food 6 hours before FMT. Patients will be given Ondansetron intravenously 1 hour before FMT. Patients will be injected 200\~300 ml fecal microbiome fluid to left colon by Colonoscopy or duodenum through duodenal tube by gastroscopy. If patient's condition is stable or improved within 1 week, second FMT may be performed 1 week later, up to 4 times will be performed if patient response. If patient's condition is not improved after the second FMT, ceasing FMT.
Trial arms
Trial start
2018-12-13
Estimated PCD
2024-03-30
Trial end
2024-04-15
Status
Completed
Phase
Early phase I
Treatment
fecal microbiome transplantation
1. Stop antibiotics treatment 1 day before fecal microbiome transplantation;
2. Fasting food 6 hours before fecal microbiome transplantation;
3. Give Ondansetron intravenously 1 hour before fecal microbiome transplantation for vomiting prevention;
4. Perform fecal microbiome transplantation under colonoscopy or gastroscopy;
5. Perform up to 4 times if patient response;
6. Stop if no response after twice fecal microbiome transplantation.
Arms:
fecal microbiome transplantation
Size
6
Primary endpoint
Response rate
12 weeks within FMT
Eligibility criteria
Inclusion Criteria:
1. Age\>= 14 yrs ≤60 yrs.
2. Diagnosed with hematological diseases.
3. Recipients of allogeneic peripheral blood stem cell transplantation.
4. Steroid resistant/dependent acute intestinal graft-versus-host disease (GVHD) within 100 days post-transplantation. The definition of steroid resistant/dependent acute intestinal GVHD is progression within 3 days of starting treatment or an incomplete response by 7 days or recurrence after initial dose reduction.
5. Eastern Cooperative Oncology Group (ECOG) score ≤2;
6. Signed consent form.
Exclusion Criteria:
1. Complicated with uncontrolled severe infection except intestine and colon.
2. High risk of hemorrhage, dysfunction of coagulation, active gastrointestinal hemorrhage;
3. Absolute neutrophil count (ANC) \<0.5×10e9/L or platelet count (PLT) \< 20×10e9/L
4. Severe organ dysfunction, including heart failure, respiratory failure, renal failure, epilepsy or central nervous system dysfunction.
5. Participating other clinical trials.
6. Pregnant women.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'fecal microbiome transplantation for patients with steroid resistant/dependent acute gastroinstestinal graft versus host disease', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 6, 'type': 'ACTUAL'}}
Updated at
2024-04-23
1 organization
1 product
1 indication
Indication
Hematopoietic and Lymphoid Cell Neoplasm