GVHD
Conditions
Keywords
GVHD
Brief summary
This clinical study evaluates the safety and efficacy of fecal microbiota transplantation (FMT) in patients with steroid-refractory graft-versus-host disease (GVHD).
Interventions
FMT in patients with refractory GVHD
Sponsors
Nanfang Hospital, Southern Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Able and willing to sign the informed consent form and complete follow-up; 2. Aged 18-65 years, regardless of gender; 3. Patients with refractory GVHD.
Exclusion criteria
1. life-threatening or associated with severe non-GvHD complications; 2. Persistent malignant conditions; 3. Patients who have undergone second or multiple hematopoietic stem cell transplants; 4. History of severe allergic reactions; 5. Any condition that the investigator considers unsuitable for inclusion (such as any history, treatment history, or abnormal test data that may confound the study results, interfere with full participation in the study, or harm the patient's interests);
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate (ORR) | 12 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Experiencing an Adverse Event (AE) | 12 weeks | 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. |
Countries
China
Outcome results
None listed