Feasibility of prebiotic fibre supplementation during allogeneic stem cell transplantatio

Phase 1

• Conditions: haematological cancer; allogeneic stem cell transplantation; Blood - Haematological diseases; Diet and Nutrition - Other diet and nutrition disorders; Cancer - Leukaemia - Acute leukaemia; Cancer - Leukaemia - Chronic leukaemia; Cancer - Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma

• Registration Number: ACTRN12624000262505
• 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: 2024-03-15
• Last Update Posted: 25 March 2024

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

Patients aged 18 or older undergoing allogeneic myeloablative or reduced intensity myeloablative allogeneic stem cell transplantation at the Royal Brisbane and Women’s Hospital (RBWH).

Exclusion Criteria

•inflammatory bowel disease
•formal diagnosis of irritable bowel syndrome
•gastrointestinal resection
•ileostomy or colostomy
•any bariatric surgery including gastric bypass surgery, sleeve gastrectomy and gastric
band
•any other contraindication to a high fibre diet (e.g. active diverticulitis or bowel
obstruction)
•allergy/ intolerance to any ingredient in the fibre supplement or enteral feed
•current and planned ongoing consumption of probiotic or prebiotic supplements
•hepatitis B, hepatitis C or HIV infection unless viral load negative
•participation in a GVHD prevention trial during SCT
•on carbamazepine
•inability to provide written informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Feasibility of prebiotic fibre supplementation, defined as consuming >80% of the prescribed supplement (oral + enteral) over the study period. [Questionnaire (designed for the study) to assess intake of the oral fibre supplement will be sent to participants weekly during the supplementation period. End of conditioning therapy then weekly until 1 month post transplant when supplementation ends. ]