Graft Versus Host Disease in GI Tract Clinical Trial
Official title:
Fecal Microbiota Transplantation in Patients With Acute Gastrointestinal Graft-versus-host-disease After Allogeneic Stem Cell Transplantation
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.
| Status | Recruiting |
| Enrollment | 15 |
| Est. completion date | December 31, 2026 |
| Est. primary completion date | March 1, 2026 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 70 Years |
| Eligibility | Inclusion Criteria: - first episode of histologically confirmed, steroid-refractory GI-aGvHD - reduced bacterial diversity in the patient´s stool microbiota evidenced by 16s-rDNA measurement - eligibility for repeated colonoscopic procedures - informed consent Exclusion Criteria: - complications during a previous colonoscopy - recurrent episode of GI-aGvHD - lacking cardiopulmonary fitness for repeated colonoscopic procedures - septic infection - acute extraintestinal organ failure (excluding bone marrow) - mechanical ileus |
| Country | Name | City | State |
|---|---|---|---|
| Austria | Division of Gastroenterology and Hepatology, Department of Internal Medicine, Medical University of Graz | Graz | Styria |
| Lead Sponsor | Collaborator |
|---|---|
| Medical University of Graz |
Austria,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | GI-aGvHD remission | Sustained remission of GI-aGvHD (CR or PR) | 90 days after first FMT | |
| Secondary | GI-aGvHD remission | Sustained remission of GI-aGvHD (CR or PR) | 45, 180 and 365 days after first FMT | |
| Secondary | Disease-free survival | GI-aGvHD free survival | 180 and 365 days after first FMT | |
| Secondary | Recurrence of GI-GvHD | Recurrence of GI-GvHD | 365 days after remission | |
| Secondary | Patient survival | Survival (death or alive) | 180 and 365 days after first FMT | |
| Secondary | SUSAR (Suspected Unexpected Serious Adverse Reaction) | Number of lethal or non-lethal SUSAR's | within 48 hours after a FMT | |
| Secondary | SAE (Serious Adverse Event) | Number of lethal or non-lethal SAE's | within 48 hours after a FMT |