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This clinical study evaluates the safety and efficacy of fecal microbiota transplantation (FMT) in patients with steroid-refractory graft-versus-host disease (GVHD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with refractory graft-versus-host disease | Experimental | FMT for patients with refractory GVHD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fecal Microbiota Transplant (FMT) | Other | FMT in patients with refractory GVHD |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) | Assessment of ORR (ORR = Complete Response (CR) + Partial Response (PR)) at 12 weeks after treatment. CR was defined as the complete resolution of all disease manifestations in every affected organ or site. PR was defined as an improvement in at least one organ or site without any disease progression occurring in other organs or sites. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Experiencing an Adverse Event (AE) | An adverse event refers to any unfavorable and unintended sign, symptom, or illness temporally associated with the use of the product, regardless of whether it is considered related to the product. A serious adverse event (SAE) is defined as an AE that results in death, is life-threatening, causes persistent or significant disability/incapacity, necessitates or extends hospitalization. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanfang hospital | Guangzhou | Guangdong | 520000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40859356 | Derived | Yang K, Du J, Huang F, Si Y, Gu Y, Xu N, Fan Z, Xue R, Wang P, Yao X, Liu H, Li X, Xu J, Wang Z, Sun J, Chen Y, Xuan L, Liu Q. Fecal microbiota transplantation for refractory chronic graft-versus-host disease after allogeneic hematopoietic cell transplantation: a pilot open-label, non-placebo-controlled study. BMC Med. 2025 Aug 26;23(1):498. doi: 10.1186/s12916-025-04336-z. |
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Only accept academic purpose for the sharing data and please contact PI with reasonable inquiring.
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| ID | Term |
|---|---|
| D000069467 | Fecal Microbiota Transplantation |
| ID | Term |
|---|---|
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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| 12 weeks |