Prospective Study of FMT for Acute Intestinal GVHD After Allo-HSCT

Study Overview
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Brief Summary
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Acute intestinal GVHD is the main cause of death after allo-HSCT, and FMT is a new treatment method for this disease. In this prospective study, the investigators will recruit intestinal GVHD patients to demonstrate the efficacy and safety of FMT.

Detailed Description
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Graft-versus-host disease (GVHD) is a common complication of allogeneic hematopoietic stem cell transplantation (allo-HSCT), of which intestinal GVHD is a particularly serious one, which is the main cause of death after allo-HSCT. Recent studies have demonstrated that intestinal flora imbalance is strongly associated with the risk of infection and mortality in patients with allo-HSCT. On the basis of this theory, fecal microbiota transplantation (FMT) may be an effective method for GVHD, that is, fecal suspension from healthy individuals is inputted into the digestive tract of patients through some methods, so as to restore the microbial community diversity of patients. In this prospective study, the investigators aimed to demonstrate the efficacy and safety of this treatment.

Official Title
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Prospective Study of Fecal Microbiota Transplantation for Acute Intestinal GVHD After Allogeneic Hematopoietic Stem Cell Transplantation

Conditions
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Acute Graft Versus Host Disease in Intestine

Intervention / Treatment
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* Biological: Fecal Microbiota Transplantation
* Drug: drug


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: received allo-HSCT due to a hematopoietic disease corticosteroid resistant/dependent intestinal GVHD ECOG≤2 Sign informed Consent No major organ dysfunction Exclusion Criteria: uncontrolled or severe infections patients with severe liver and kidney function, cardiopulmonary insufficiency, epilepsy, and central nervous system disorder high-risk bleeding ANC<0.5×10^9/L or PLT<20x10^9/L hepatitis B, tuberculosis, syphilis, and HIV antibody positive or acute phase of any infectious disease patients participating in other clinical trials patienta who suffer from mental illness

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fecal Microbiota Transplantation group<br>treat with FMT | Biological: Fecal Microbiota Transplantation<br>* fecal microbiota transplantation<br>|
| Active Comparator: Control group<br>treat with traditional medicine | Drug: drug<br>* drug<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in times of stool | Change in times of stool per day within 28 days after FMT | day 0,day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 14, day 21 and day 28. | 
| change in volume of stool | Change in volume of stool per day within 28 days after FMT | day 0,day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 14, day 21 and day 28. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in life quality up to 28 days | The change quality of patients life within 28 days after FMT is assessed by EORTC Quality of Life measurement Scale QLQ-C30 (V3.0) with a score ranged 0 100. And the higher the score, the better the functional status and quality of life | day 0,day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 14, day 21 and day 28. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute-graft-versus-host Disease, Fecal microbiota transplantation