None listed
Conditions
Brief summary
This study will determine safety and feasibility of therapeutic FMT for steroidrefractory (SR) and steroid dependent (SD) acute gastrointestinal (GI) Graftversus-Host Disease (GVHD) ocurring in patients after allogeneic bone marrow transplantation at Royal Brisbane and Women’s Hospital. It is a phase I/II open label, pilot study and will treat 10 participants. FMT is an effective therapy to restore the healthy GI microbial flora in recurrent Clostridiodes difficile (rCDI) gastroenteritis. There is emerging evidence of efficacy for FMT in GI-GVHD, an immune-mediated complication of bone marrow transplantation. FMT offers a novel and cost effective therapeutic option to reduce GVHD mortality and the morbidity associated with other secondary therapies, i.e. broad spectrum immunosuppressive treatments including Antithymocyte globulin (ATGAM). FMT will be offered in combination with standard of care including Ruxolitinib and following first line treatment with steroids. Efficacy of FMT as a therapy for SR and SD GI-GVHD will be assessed as a secondary endpoint. Laboratory samples for correlative scientific analysis will be collected to explore the mechanistic basis for therapeutic efficacy of FMT. The FMT product will be supplied by Australian Red Cross Lifeblood Microbiome, who are a TGA licenced manufacturer of voluntary donated human stool derived faecal Microbiota for transplant.
Interventions
Faecal Microbiota Transplant. A single dose of donor faecal material provided by The Australian Red Cross Lifeblood Microbiome project, will be administered via naso-duodenal tube to patients at the Royal Brisbane and Women's Hospital. Recipients will be patients who have had an allogeneic bone marrow transplant and who have steroid dependent (SD) or steroid refractory (SR) Graft-versus-Host Disease. The Faecal Microbiota for Transplant is a 150g suspension in normal saline derived from 50g of
Faecal Microbiota Transplant. A single dose of donor faecal material provided by The Australian Red Cross Lifeblood Microbiome project, will be administered via naso-duodenal tube to patients at the Royal Brisbane and Women's Hospital. Recipients will be patients who have had an allogeneic bone marrow transplant and who have steroid dependent (SD) or steroid refractory (SR) Graft-versus-Host Disease. The Faecal Microbiota for Transplant is a 150g suspension in normal saline derived from 50g of human donor stool. Admission will be directly supervised by nursing staff in the RBWH Bone Marrow Transplant Unit.
Sponsors
Metro North Hospital and Health Service
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Recipient of allogeneic bone marrow transplantation 2. Clinical and Histological diagnosis of gastrointestinal Graft-versus-Host Disease from any site in the GI tract. 3. Steroid refractory (SR) and / or steroid dependent (SD) GVHD defined as; - Progression after 3 days of 2mg/kg of Prednisone or equivalent. - No change after 7 days of 2mg/kg of Prednisone or equivalent. - Incomplete response (<50% reduction in stool volume) after 14 days of 2mg/kg of Prednisone or equivalent. - Recurrence on steroid taper when receiving >50mg of prednisolone per day. 4. Ability to provide voluntary informed consent
Exclusion criteria
1. Contraindication or inability to insert a naso-duodenal tube; including cytopenias which prevent safe insertion of naso-duodenal tube despite transfusional support. 2. Active uncontrolled bacterial, fungal or viral infections 3. Pregnancy or breast feeding
Outcome results
None listed