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Trial registered on ANZCTR


Registration number
ACTRN12622000895785
Ethics application status
Approved
Date submitted
7/06/2022
Date registered
23/06/2022
Date last updated
28/04/2024
Date data sharing statement initially provided
23/06/2022
Date results information initially provided
28/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
FIBRE-PD: prospective randomised feasibility trial investigating bulk forming laxative adherence and effectiveness in peritoneal dialysis patients.
Scientific title
FIBRE-PD: prospective randomised feasibility trial investigating bulk forming laxative adherence and effectiveness in peritoneal dialysis patients,
Secondary ID [1] 306519 0
Nil known
Universal Trial Number (UTN)
Trial acronym
FIBRE-PD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
constipation 325403 0
peritoneal dialysis 326691 0
kidney disease 326692 0
Condition category
Condition code
Renal and Urogenital 322791 322791 0 0
Kidney disease
Oral and Gastrointestinal 323934 323934 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention in this study is natural soluble fibre supplement, psyllium husk. Patients will be advised to administer 1 x 20mL scoop, which is 10g equivalent dose, of psyllium husk mixed with a full glass of water daily at their own home and monitor their bowel frequency for four weeks (first dose administered in the peritoneal dialysis unit). They may also choose to mix it with soft food if they prefer. They will be contacted via telephone on day 3 and advised to increase dose to 10g twice a day if they have not experienced daily bowel motion, which will continued to be monitored and advised as clinically indicated during each study visit (weekly) (with a maximal dose 30g/day). Weekly study visits will occur via telephone at week 1, 2 and 3 and in person on week 4 (end study visit). Nurses in the peritoneal dialysis unit involved in the study will conduct the visit. Weeks 1, 2 and 3 study visits via telephone will take 6-7 minutes each and the end study visit will take no more than 30 minutes to complete.
Intervention code [1] 322951 0
Lifestyle
Intervention code [2] 322952 0
Prevention
Comparator / control treatment
The comparator (control) in this study is Movicol®, which is a type of osmotic laxative. Participants will continue with their usual dose of daily Movicol®, which will be adjusted as clinically indicated with the goal to achieve a daily bowel motion over the course of the four week study, Participants will have study visits via telephone at week 1, 2 and 3 and in person on week 4 (end study visit). Nurses in the peritoneal dialysis unit involved in the study will conduct the visit.
Control group
Active

Outcomes
Primary outcome [1] 330579 0
Feasibility outcome:
Ability to successfully recruit 60 patients within 12 months, determined by an audit of study enrolment logs.
Timepoint [1] 330579 0
12 months post recruitment commencement
Primary outcome [2] 330726 0
Adherence:
Proportion of patients who continue to take psyllium husk over the period of the study
Adherence will be defined as taking more than 80% of the prescribed study therapy at week 4 which will be measured by evaluating the daily dose of study therapy.
- Psyllium husk group (intervention): original weight – final weight / number of days taking Psyllium husk
- Movicol group (control): Number of sachets used / number of days taking Movicol
A daily checklist will be provided at study commencement for all participants.
Timepoint [2] 330726 0
Four weeks post intervention commencement
Primary outcome [3] 331764 0
Feasibility outcome:
Proportion of eligible patients who agree to take part in the study, determined by an audit of study enrolment logs and patient tracking spreadsheet.
Timepoint [3] 331764 0
12 months post recruitment commencement
Secondary outcome [1] 407592 0
3. Retention
Proportion of patients who remain in the study for follow-up for the entire study period (patients who do not withdraw their consent and complete all study requirements), determined by an audit of study enrolment and withdrawal logs.
Timepoint [1] 407592 0
Four weeks post intervention commencement
Secondary outcome [2] 407593 0
4. Patient-reported outcomes
Changes in the overall quality of life (measured using the Edmonton Symptom assessment scale) completed at day of consent and end study visit
Timepoint [2] 407593 0
Baseline and on completion at four weeks post intervention commencement,
Secondary outcome [3] 407594 0
5. Clinical outcomes
Bowel motion (frequency of bowel movements [over 3 days] assessed using Bristol Stool Score.
Timepoint [3] 407594 0
Baseline, week 1, week 2, week 3 and week 4 post intervention commencement
Secondary outcome [4] 407595 0
6.Safety outcomes
Biochemistry parameters: proportion of patients with hyperkalaemia (>6mmol/L) requiring treatment, assessed by blood test and review of medical records
Timepoint [4] 407595 0
Week 2 post intervention commencement
Secondary outcome [5] 410924 0
4. Patient reported outcomes.
Changes in the Gastrointestinal Symptom Rating Scale, completed on day of consent and at their end study visit
Timepoint [5] 410924 0
Baseline and four weeks post study intervention commencement,
Secondary outcome [6] 410925 0
5. Clinical outcomes
Catheter malfunction requiring intervention (poor flow/blocked catheter requiring intervention [e.g. medications such as heparin or urokinase/procedure to reposition or replace catheter]) determined by review of medical records.
Timepoint [6] 410925 0
Day 3, 1, 2, 3 and 4 weeks post-intervention commencement
Secondary outcome [7] 410926 0
5. Clinical outcomes
Episodes of volume overload requiring hospital admission, assessed by review of hospital records
Timepoint [7] 410926 0
Day 3, 1, 2, 3 and 4 weeks post-intervention commencement
Secondary outcome [8] 410927 0
6. Safety Outcomes
Serious adverse events: death, unplanned hospitalisations will be captured will be captured from medical records.
Timepoint [8] 410927 0
1, 2, 3 and 4 weeks post-intervention commencement

Eligibility
Key inclusion criteria
To be eligible to participate in this study, participants must satisfy all of the following criteria:
- Patients who have received Peritoneal Dialysis for at least 3 months
- Aged 18 years or over
- Currently taking Movicol® (osmotic laxative) to regulate their bowel motion
- Able to provide informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be excluded from participation if they meet any of the following criteria:
- Have received radiation to the bowel or large bowel resection
- Medically diagnosed and active inflammatory bowel disease
- Unwilling or unable to meet the requirements of the protocol
- Has a physical, medical or psychological condition that, in the opinion of the lead investigator, may interfere with study participation.
- No plans for commencing/recently commenced any new dietary therapy during the trial duration

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The randomisation schedule will be prepared by a researcher not involved with treatment allocation and will involve stratification factors of daily Movicol® dose (less than 3, equal to or greater than 3 sachets/day).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomly assigned in a 1:1 ratio to receive either Psyllium husk or continue Movicol®.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Our main interest is precise estimates of feasibility and adherence, that will help in the planning of a larger, sufficiently powered trial. For example, with a total sample size of 60, if we observe a 70% recruitment rate out of those eligible and 80% adherence rate, the 95% CI will be (58%, 82%) and (66%,94%), respectively.
Statistical analysis:
Feasibility and recruitment will be estimated as a proportion. For continuous outcomes, quality of life, gut motility and burden of gastrointestinal symptom, mean change from baseline will be estimated as using linear regression. Variability and mean differences between intervention and standard of care will also be estimated to help inform future studies. A statistical analysis plan will be developed before the data lock.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
27/06/2022
Actual
11/10/2022
Date of last participant enrolment
Anticipated
30/06/2023
Actual
11/10/2023
Date of last data collection
Anticipated
28/07/2023
Actual
8/11/2023
Sample size
Target
60
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 21837 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 36896 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 310863 0
Hospital
Name [1] 310863 0
Queensland Advancing Research Fellowship
Country [1] 310863 0
Australia
Primary sponsor type
Hospital
Name
Department of Nephrology, Princess Alexandra Hospital
Address
199 Ipswich Rd, Woolloongabba QLD 4102
Country
Australia
Secondary sponsor category [1] 313103 0
None
Name [1] 313103 0
Address [1] 313103 0
Country [1] 313103 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310425 0
Human Research Ethics Committee, Metro South Research, Metro South Hospital and Health Service
Ethics committee address [1] 310425 0
Level 7, Translational Research Institute Building
Princess Alexandra Hospital
Ipswich Road, Woolloongabba Qld 4102
Ethics committee country [1] 310425 0
Australia
Date submitted for ethics approval [1] 310425 0
21/12/2021
Approval date [1] 310425 0
17/03/2022
Ethics approval number [1] 310425 0
HREC/2022/QMS/76238

Summary
Brief summary
FIBRE-PD is a prospective parallel-arm open-label randomised controlled study which aims to explore recruitment, adherence, efficacy and safety of implementing psyllium husk to patients receiving PD with constipation compared to standard care. Sixty prevalent PD patients will be recruited from the PD unit at the Princess Alexandra Hospital Participants will be randomly assigned in a 1:1 ratio to receive either Psyllium husk or continue Movicol®. Key objectives to be assessed in this feasibility randomised controlled trial include, whether:
1. Eligible PD patients can be recruited to take psyllium husk
2. PD patients will adhere to psyllium husk administered to maintain gut motility
3. PD patients will withdraw from a randomised controlled trial when Psyllium husk is administered to reduce gastrointestinal symptom burden and to help maintain gut motility
4. Psyllium husks help maintain gut motility, reduce gastrointestinal symptom burden and improve quality of life in PD patients
Hypotheses include:
1. The FIBRE-PD study will be able to successfully recruit 60 patients within twelve months.
2. PD patients allocated to receive psyllium husk will adhere to treatment during the study (defined as >80% of treatment administered).
3. PD patients will not withdraw (10% or less withdrawal) from the study examining the safety and efficacy of psyllium husk as a gut health intervention strategy in PD.
4. Psyllium husk in PD patients will result in improved quality of life during the 4-week study period.
5. Psyllium husk supplementation in PD patients will maintain gut motility and reduce the burden of gastrointestinal symptom measured using Bristol stool score, frequency and Gastrointestinal Symptom Rating Scale.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 117622 0
Mrs Chloe Howard
Address 117622 0
Peritoneal Dialysis Unit
Level 2, Burke Street Centre
2 Burke Street, Woolloongabba
QLD 4102
Country 117622 0
Australia
Phone 117622 0
+61731761251
Fax 117622 0
Email 117622 0
Chloe.Howard@health.qld.gov.au
Contact person for public queries
Name 117623 0
Mrs Chloe Howard
Address 117623 0
Peritoneal Dialysis Unit
Level 2, Burke Street Centre
2 Burke Street, Woolloongabba
QLD 4102
Country 117623 0
Australia
Phone 117623 0
+61731761251
Fax 117623 0
Email 117623 0
Chloe.Howard@health.qld.gov.au
Contact person for scientific queries
Name 117624 0
Mrs Chloe Howard
Address 117624 0
Peritoneal Dialysis Unit
Level 2, Burke Street Centre
2 Burke Street, Woolloongabba
QLD 4102
Country 117624 0
Australia
Phone 117624 0
+61731761251
Fax 117624 0
Email 117624 0
Chloe.Howard@health.qld.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual Participant data that underlie the results reported in the primary publication, after de-identification (text, tables, figures and appendices). Medicare and all other administrative data will not be available.
When will data be available (start and end dates)?
Beginning 2 years after the pre-specified analyses. There is no set end date for data sharing.
Available to whom?
Researchers with a methodologically sound proposal that has been approved by the Trial Steering Committee.
Available for what types of analyses?
To achieve the aims of the approved proposal.
How or where can data be obtained?
Once approval has been granted, deidentified data will be accessible to researchers to complete their analyses via secured portal.
Contact details for the Trial Steering Committee:
email: chloe.howard@health.qld.gov.au
phone: +61 7 3176 1251


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.