None listed
Conditions
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.
Interventions
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
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.
Sponsors
Department of Nephrology, Princess Alexandra Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
Outcome results
None listed