FIBRE-PD: prospective randomised feasibility trial investigating bulk forming laxative adherence and effectiveness in peritoneal dialysis patients.

Not Applicable

Completed

• Conditions: constipation; peritoneal dialysis; kidney disease; Renal and Urogenital - Kidney disease; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12622000895785
• Lead Sponsor: Department of Nephrology, Princess Alexandra Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-23
• Study Completion: 2023-11-08
• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 20

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

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

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Feasibility outcome:<br>Ability to successfully recruit 60 patients within 12 months, determined by an audit of study enrolment logs.[ 12 months post recruitment commencement];Adherence:<br>Proportion of patients who continue to take psyllium husk over the period of the study<br>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. <br> - Psyllium husk group (intervention): original weight – final weight / number of days taking Psyllium husk <br> - Movicol group (control): Number of sachets used / number of days taking Movicol <br>A daily checklist will be provided at study commencement for all participants.[ Four weeks post intervention commencement];Feasibility outcome:<br>Proportion of eligible patients who agree to take part in the study, determined by an audit of study enrolment logs and patient tracking spreadsheet.[ 12 months post recruitment commencement]