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| Name | Class |
|---|---|
| Peking University People's Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fecal Microbiota Transplantation group | Experimental | treat with FMT |
|
| Control group | Active Comparator | treat with traditional medicine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fecal Microbiota Transplantation | Biological | fecal microbiota transplantation |
|
| 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shuqian Xu | Contact | +86 0531-88382169 | shuqian.xu@email.sdu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Shuqian Xu | Qilu Hospital of Shandong University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking university people's hospital | Recruiting | Beijing | Beijing Municipality | 100044 | China |
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| ID | Term |
|---|---|
| D000069467 | Fecal Microbiota Transplantation |
| D004364 | Pharmaceutical Preparations |
| ID | Term |
|---|---|
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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| drug | Drug | drug |
|
| Shandong university qilu hospital | Not yet recruiting | Jinan | Shandong | 250012 | China |
|