Faecal Microbial Transplantation for Graft-Versus-Host Disease

Not Applicable

• Conditions: Graft-versus-Host Disease; Bone Marrow Transplantation; Blood - Haematological diseases; Inflammatory and Immune System - Other inflammatory or immune system disorders

• Registration Number: ACTRN12622000797774
• Lead Sponsor: Metro North Hospital and Health Service

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-06-07
• Last Update Posted: 13 June 2022

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified