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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Steroid refractory GI-aGvHD | Experimental | Patients with GI-aGvHD not sufficiently responding to GvHD therapy with corticosteroids. Intervention: Fecal microbiota transplantation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fecal microbiota transplantation | Biological | 200 ml of a tested stool suspension of a healthy donor is instilled into the patient´s caecum or terminal ileum |
|
| Measure | Description | Time Frame |
|---|---|---|
| GI-aGvHD remission | Sustained remission of GI-aGvHD (CR or PR) | 90 days after first FMT |
| Measure | Description | Time Frame |
|---|---|---|
| GI-aGvHD remission | Sustained remission of GI-aGvHD (CR or PR) | 45, 180 and 365 days after first FMT |
| Disease-free survival | GI-aGvHD free survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Walter DDr. Spindelboeck | Contact | 0043 316 385 30195 | walter.spindelboeck@medunigraz.at |
| Name | Affiliation | Role |
|---|---|---|
| Peter Prof. Dr. Neumeister | Department of Internal Medicine, Division of Hematology, Medical University of Graz | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Gastroenterology and Hepatology, Department of Internal Medicine, Medical University of Graz | Recruiting | Graz | Styria | 8036 | Austria |
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| ID | Term |
|---|---|
| D000069467 | Fecal Microbiota Transplantation |
| ID | Term |
|---|---|
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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Patients with acute gastrointestinal graft-versus-host disease refractory to steroid treatment
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| 180 and 365 days after first FMT |
| Recurrence of GI-GvHD | Recurrence of GI-GvHD | 365 days after remission |
| Patient survival | Survival (death or alive) | 180 and 365 days after first FMT |
| SUSAR (Suspected Unexpected Serious Adverse Reaction) | Number of lethal or non-lethal SUSAR's | within 48 hours after a FMT |
| SAE (Serious Adverse Event) | Number of lethal or non-lethal SAE's | within 48 hours after a FMT |