None listed
Conditions
Brief summary
This pilot study is evaluating the feasibility of providing an oral prebiotic fibre supplement during treatment for acute leukemia. It will assess tolerance and whether prebiotic supplementation can improve the microbiome and reduce complications. Patients may be eligible to join this study if they are aged 18 years and older undergoing treatment for acute leukemia at the Royal Brisbane and Women’s Hospital (RBWH). Participants in this study will be randomly allocated to the intervention group or the control group. Participants allocated to the intervention will receive an oral prebiotic fibre supplement from the start of induction treatment until the end of their consolidation treatment. The control group will receive usual care. It is hoped that prebiotic supplementation will support the microbiome and improve health outcomes for participants undergoing acute leukemia treatment.
Interventions
This trial evaluates feasibility of an oral prebiotic fibre supplement during treatment for acute leukemia and the impact on clinical outcomes, the microbiome and immune function. The trial will take place on the haematology unit at the Royal Brisbane and Women's Hospital. The trial compares oral prebiotic supplementation (group 1) to standard care (group 2).
Group 1 will commence an oral prebiotic fibre supplement from the start of induction treatment after diagnosis and continue until the e
This trial evaluates feasibility of an oral prebiotic fibre supplement during treatment for acute leukemia and the impact on clinical outcomes, the microbiome and immune function. The trial will take place on the haematology unit at the Royal Brisbane and Women's Hospital. The trial compares oral prebiotic supplementation (group 1) to standard care (group 2). Group 1 will commence an oral prebiotic fibre supplement from the start of induction treatment after diagnosis and continue until the end of consolidation chemotherapy. The supplement will be provided for 3-6 months depending on number of consolidation cycles required. The prebiotic is a powdered fibre supplement mix of inulin, resistant starch and psyllium, split into two doses. Two sachets per day will provide a combined dose of 22g fibre per day. Participants will be advised to take the supplement with a meal and to commence 1 sachet per day for the first 3 days then increase to 2 sachets per day. Adherence will be measured by patients reporting consumption fortnightly (number of sachets provided compared to number remaining each fortnight and whether full sachets were consumed).
Sponsors
Metro North Hospital and Health Service
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• age 18 years or older • newly diagnosed acute leukemia or myelodysplasia undergoing high intensity intravenous induction chemotherapy at the Royal Brisbane and Women’s Hospital (RBWH) • ability to provide written informed consent
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 • a contraindication to a high fibre diet (e.g. active diverticulitis or bowel obstruction) • allergy/ intolerance to any ingredient in the fibre supplement • current and planned ongoing consumption of probiotic or prebiotic supplement • hepatitis B, hepatitis C or HIV infection unless viral load negative • on carbamazepine • inability to provide written informed consent
Outcome results
None listed