Acute graft-versus-host-disease (aGvHD) is a typical complication after allogeneic hematopoetic stem cell transplantation (ASCT). About 30-60% of patients after ASCT are affected by aGvHD, which constitutes a relevant burden of morbidity and mortality in these patients. Fecal microbiota transplantation (FMT) is a therapeutic concept to treat intestinal dysbiosis of various origin by infusion of the stool microbiota of a healthy donor into the gastrointestinal tract (GI) of a patient. FMT can be performed endoscopically by colonoscopic deployment of the donor microbiota into the patient´s caecum and terminal ileum. Patients with gastrointestinal aGvHD (GI-aGvHD) are known to comprise a significant dysbiotic colonic microbiota that can be attenuated by FMT.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
200 ml of a tested stool suspension of a healthy donor is instilled into the patient´s caecum or terminal ileum
Division of Gastroenterology and Hepatology, Department of Internal Medicine, Medical University of Graz
Graz, Styria, Austria
RECRUITINGGI-aGvHD remission
Sustained remission of GI-aGvHD (CR or PR)
Time frame: 90 days after first FMT
GI-aGvHD remission
Sustained remission of GI-aGvHD (CR or PR)
Time frame: 45, 180 and 365 days after first FMT
Disease-free survival
GI-aGvHD free survival
Time frame: 180 and 365 days after first FMT
Recurrence of GI-GvHD
Recurrence of GI-GvHD
Time frame: 365 days after remission
Patient survival
Survival (death or alive)
Time frame: 180 and 365 days after first FMT
SUSAR (Suspected Unexpected Serious Adverse Reaction)
Number of lethal or non-lethal SUSAR's
Time frame: within 48 hours after a FMT
SAE (Serious Adverse Event)
Number of lethal or non-lethal SAE's
Time frame: within 48 hours after a FMT
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