Clinical trial · Interventional
Fecal Microbiota Transplantation for Steroid Resistant/Dependent Acute GI GVHD
Fecal Microbiota Transplantation for the Treatment of Steroid Resistant/Dependent Acute Gastrointestinal Graft Versus Host Disease
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematopoietic and Lymphoid Cell Neoplasm | Hematopoietic and Lymphoid Cell Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| fecal microbiome transplantation | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- fecal microbiome transplantation
- description
- 1. Perform fecal microbiome transplantation to patient under colonoscopy or gastroscopy: injection of 200\~300 ml fecal microbiome fluid as fecal microbiome transplantation to left colon by Colonoscopy or duodenum through duodenum tube by gastroscopy; 2. If patient's condition is stable or improved within 1 week, second fecal microbiome transplantation may be performed 1 week later, up to 4 times will be performed if patient response; 3. If patient's condition is not improved after the second fecal microbiome transplantation, stop fecal microbiome transplantation.
- interventionNames
- Biological: fecal microbiome transplantation
Primary outcomes (1)
- measure
- Response rate
- timeFrame
- 12 weeks within FMT
- description
- Response rate of acute gastrointestinal GVHD after FMT, including complete response and partial response.
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 14 Years
- Maximum age
- 60 Years
Show eligibility criteria text
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.
References
Publications (0)
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