Graft Versus Host Disease in GI Tract
Conditions
Brief summary
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.
Interventions
BIOLOGICALFecal microbiota transplantation
200 ml of a tested stool suspension of a healthy donor is instilled into the patient´s caecum or terminal ileum
Sponsors
Medical University of Graz
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Patients with acute gastrointestinal graft-versus-host disease refractory to steroid treatment
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| GI-aGvHD remission | 90 days after first FMT | Sustained remission of GI-aGvHD (CR or PR) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease-free survival | 180 and 365 days after first FMT | GI-aGvHD free survival |
| Recurrence of GI-GvHD | 365 days after remission | Recurrence of GI-GvHD |
| GI-aGvHD remission | 45, 180 and 365 days after first FMT | Sustained remission of GI-aGvHD (CR or PR) |
| SUSAR (Suspected Unexpected Serious Adverse Reaction) | within 48 hours after a FMT | Number of lethal or non-lethal SUSAR's |
| SAE (Serious Adverse Event) | within 48 hours after a FMT | Number of lethal or non-lethal SAE's |
| Patient survival | 180 and 365 days after first FMT | Survival (death or alive) |
Countries
Austria
Contacts
Primary ContactWalter DDr. Spindelboeck
Outcome results
None listed