Feasibility of prebiotic fibre supplementation during allogeneic stem cell transplantation
Feasibility of prebiotic fibre supplementation during allogeneic stem cell transplantation, a pilot randomised control trial
Metro North Hospital and Health Service
36 participants
Sep 18, 2024
Interventional
Conditions
Summary
This pilot study is evaluating the feasibility of providing an oral plus enteral prebiotic fibre supplementation and assess tolerance and whether this can improve the microbiome and reduce complications in patients receiving an allogeneic stem cell transplant Who is it for? You may be eligible to join this study if you are aged 18 years and older undergoing allogeneic myeloablative or reduced intensity myeloablative allogeneic stem cell transplantation at the Royal Brisbane and Women’s Hospital (RBWH). Study details Participants in this study will be randomly allocated by chance (similar to flipping a coin) to the intervention group or the control group. Participants allocated to the intervention will receive an oral prebiotic fibre supplement from a week prior to the start of conditioning therapy and continue it until a month post stem cell transplant (SCT) and prebiotic enteral nutrition (EN) starting day one post SCT until required. The control group will receive a non-fibre EN formula from day one post SCT as per usual care. Participants will then be followed-up and assessed weekly for 4 weeks post SCT to determine feasibility and effectiveness of an oral plus enteral prebiotic fibre supplementation in patients receiving an allogeneic stem cell transplant. It is hoped that this research will support the microbiome and improve health outcomes for participants undergoing allogeneic SCT.
Eligibility
Inclusion Criteria1
- 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 Criteria14
- 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
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Interventions
This trial evaluates feasibility of oral plus enteral prebiotic fibre supplementation during allogeneic stem cell transplantation (SCT) 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 and enteral supplementation (group 1) to standard care (group 2). Group 1: Oral and enteral prebiotic supplement The intervention group will commence an oral prebiotic fibre supplement from a week prior to the start of conditioning therapy and continue it until a month post SCT. 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. The intervention group will commence fibre containing EN on day one post SCT and increase the feeding rate as per usual care. Participants will receive a polymeric ready to hang formula containing inulin, oligofructose, arabic gum, soy polysaccharides, cellulose and resistant starch providing 10-28g fibre per day (depending on the feeding rate required). Participants receiving partial prebiotic EN (at 30ml/hr or 50ml/hr) to meet part of their nutritional requirements will be encouraged to continue 1 prebiotic fibre oral sachet per day. Participants receving full rate prebiotic EN (>50ml/hr) to meet full estimated nutritional requirements (due to consuming minimal or nil oral intake) can cease the oral prebiotic supplement, Once EN reduces to meet partial requirements the oral prebiotic supplement will recommence at 1 sachet per day. Once EN ceases participants will be encouraged to take 2 sachets per day until study cessation. Adherence to prebiotic fibre supplementation will be measured by participants reporting the number of prebiotic fibre sachets consumed weekly. Additionally during provision of prebiotic enteral nutrition the amount provided will be collected from fluid balance charts. Group 2: Standard care. This group will receive standard fibre free enteral nutrition from day one after transplant as per usual care. The feeding commencement time, rate and cessation will be as per usual care ( the same as group 1.)
Locations(1)
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ACTRN12624000262505