This clinical study evaluates the safety and efficacy of fecal microbiota transplantation (FMT) in patients with steroid-refractory graft-versus-host disease (GVHD).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
46
FMT in patients with refractory GVHD
Nanfang hospital
Guangzhou, Guangdong, China
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.
Time frame: 12 weeks
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.
Time frame: 12 weeks
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