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Trial registered on ANZCTR


Registration number
ACTRN12624000262505p
Ethics application status
Submitted, not yet approved
Date submitted
7/02/2024
Date registered
15/03/2024
Date last updated
15/03/2024
Date data sharing statement initially provided
15/03/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Feasibility of prebiotic fibre supplementation during allogeneic stem cell transplantation
Scientific title
Feasibility of prebiotic fibre supplementation during allogeneic stem cell transplantation, a pilot randomised control trial
Secondary ID [1] 311485 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
haematological cancer 332811 0
allogeneic stem cell transplantation 332812 0
Condition category
Condition code
Blood 329525 329525 0 0
Haematological diseases
Diet and Nutrition 329526 329526 0 0
Other diet and nutrition disorders
Cancer 329787 329787 0 0
Leukaemia - Acute leukaemia
Cancer 329788 329788 0 0
Leukaemia - Chronic leukaemia
Cancer 329789 329789 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.)
Intervention code [1] 327937 0
Treatment: Other
Comparator / control treatment
Participants in the control group will receive a non-fibre EN formula from day one post SCT as per usual care (following the RBWH ‘Allogeneic stem cell transplant nutrition support protocol’). This involves provision of a polymeric non-fibre ready to hang formula. The feeding rate will increase if oral intake declines as per usual care. Tolerance of EN in both the control and intervention group will be monitored and if poor, participants will be changed to parenteral nutrition as per standard care.
Control group
Active

Outcomes
Primary outcome [1] 337323 0
Feasibility of prebiotic fibre supplementation, defined as consuming >80% of the prescribed supplement (oral + enteral) over the study period.
Timepoint [1] 337323 0
End of conditioning therapy then weekly until 1 month post transplant when supplementation ends.
Secondary outcome [1] 431443 0
Amount of prescribed enteral nutrition received
Timepoint [1] 431443 0
Collected daily during provision of enteral nutrition
Secondary outcome [2] 431444 0
Patient acceptability of the oral prebiotic supplement
Timepoint [2] 431444 0
At the end of conditioning treatment and at the end of supplementation
Secondary outcome [3] 431445 0
Appetite
Timepoint [3] 431445 0
At baseline pre supplementation then weekly from the end of conditioning to 1 month post transplant at the end of supplementation.
Secondary outcome [4] 431446 0
Quality of life
Timepoint [4] 431446 0
At baseline and at the end of supplementation
Secondary outcome [5] 431447 0
Unplanned hospital admissions by 100 days post transplant
Timepoint [5] 431447 0
Assessed at day 100 post transplant
Secondary outcome [6] 431448 0
Duration of enteral nutrition
Timepoint [6] 431448 0
Assessed at hospital discharge
Secondary outcome [7] 431449 0
Requirement for parenteral nutrition
Timepoint [7] 431449 0
The number of participants who required parenteral nutrition will be assessed on hospital discharge
Secondary outcome [8] 431450 0
Nutritional status
Timepoint [8] 431450 0
At baseline and at the end of supplementation
Secondary outcome [9] 431451 0
Dietary intake
Timepoint [9] 431451 0
At baseline then weekly from the end of conditioning to the end of supplementation
Secondary outcome [10] 431452 0
Length of hospital stay
Timepoint [10] 431452 0
At hospital discharge
Secondary outcome [11] 431453 0
Incidence of infections
Timepoint [11] 431453 0
Collected continuously from study commencement to 100 days post transplant
Secondary outcome [12] 431454 0
Acute graft versus host disease
Timepoint [12] 431454 0
Day 100 post transplant
Secondary outcome [13] 431455 0
disease status
Timepoint [13] 431455 0
day 100 post transplant
Secondary outcome [14] 431456 0
Survival
Timepoint [14] 431456 0
Day 100 after transplant
Secondary outcome [15] 432314 0
Nausea
Timepoint [15] 432314 0
At baseline pre supplementation then weekly from the end of conditioning to 1 month post transplant at the end of supplementation.
Secondary outcome [16] 432315 0
mucositis
Timepoint [16] 432315 0
At baseline pre supplementation then weekly from the end of conditioning to 1 month post transplant at the end of supplementation.
Secondary outcome [17] 432316 0
diarrhoea
Timepoint [17] 432316 0
At baseline pre supplementation then weekly from the end of conditioning to 1 month post transplant at the end of supplementation.

Eligibility
Key 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).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Yes, the investigator recruiting participants will be unable to see which group they will be allocated to until after recruitment when the randomisation will be completed in RedCap. In RedCap future allocations are concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created
by computer software then entered into Redcap database by an investigator not involved in recruitment.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
8/04/2024
Actual
Date of last participant enrolment
Anticipated
7/04/2025
Actual
Date of last data collection
Anticipated
31/07/2025
Actual
Sample size
Target
36
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 315772 0
Charities/Societies/Foundations
Name [1] 315772 0
ASPEN Rhoades Research Foundation
Country [1] 315772 0
United States of America
Funding source category [2] 315777 0
Hospital
Name [2] 315777 0
RBWH Project grant
Country [2] 315777 0
Australia
Primary sponsor type
Hospital
Name
Metro North Hospital and Health Service
Address
Country
Australia
Secondary sponsor category [1] 317901 0
None
Name [1] 317901 0
Address [1] 317901 0
Country [1] 317901 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 314632 0
Metro North Health Human Research Ethics Committee A
Ethics committee address [1] 314632 0
https://metronorth.health.qld.gov.au/research/ethics-and-governance/human-research-ethics-committee
Ethics committee country [1] 314632 0
Australia
Date submitted for ethics approval [1] 314632 0
29/11/2023
Approval date [1] 314632 0
Ethics approval number [1] 314632 0

Summary
Brief 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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 132222 0
Dr Sarah Andersen
Address 132222 0
Dietetics and Foodservices, Royal Brisbane and Women's Hospital. Butterfield Street, Herston, QLD, 4029
Country 132222 0
Australia
Phone 132222 0
+617 36468268
Fax 132222 0
Email 132222 0
[email protected]
Contact person for public queries
Name 132223 0
Sarah Andersen
Address 132223 0
Dietetics and Foodservices, Royal Brisbane and Women's Hospital. Butterfield Street, Herston, QLD, 4029
Country 132223 0
Australia
Phone 132223 0
+617 36468268
Fax 132223 0
Email 132223 0
[email protected]
Contact person for scientific queries
Name 132224 0
Sarah Andersen
Address 132224 0
Dietetics and Foodservices, Royal Brisbane and Women's Hospital. Butterfield Street, Herston, QLD, 4029
Country 132224 0
Australia
Phone 132224 0
+617 36468268
Fax 132224 0
Email 132224 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.