Pilot randomised controlled trial evaluating feasibility, safety and adherence to psyllium husk in peritoneal dialysis: The FIBRE-PD trial

Background Patients receiving peritoneal dialysis (PD) often report problems with constipation. Constipation in PD is associated with increased risks of mechanical and infectious complications, such as poor drainage and fluid removal, catheter migration and peritonitis. A natural fibre supplement, psyllium husk, has been identified as a potential alternative therapy to minimise the risk of constipation for patients receiving PD. Methods FIBRE-PD is a prospective parallel-arm open-label feasibility study in which patients on PD were 1:1 randomly assigned to receive either psyllium husk (intervention group) or continue routine Movicol ® (control group) for four weeks (28 days). The primary outcome was feasibility, defined as successful recruitment of 60 patients, representing 70% of eligible PD patients. Secondary outcomes included adherence, retention, safety, bowel frequency and patient-reported outcomes (e.g., gastrointestinal symptom burden, quality of life). Results Overall, 96 patients were screened for eligibility. Sixty-six (69%) were deemed not eligible, mainly due to non-adherence to prescribed regular Movicol ( n = 41, 62%). Among 30 eligible patients, 20 patients (67% of eligible population) were successfully recruited into the study. The intervention group demonstrated high retention (77%), adherence rates (78%) and significant improvement in gastrointestinal symptoms and quality of life compared to patients in the control group. No adverse outcomes were reported. Conclusion The FIBRE-PD did not meet its original recruitment target due to an unexpectedly high number of ineligible patients. The recruited proportion almost reached the pre-specified target of 70% of eligible patients, and participants in the intervention group demonstrated high retention and adherence rates with observed benefits in gastrointestinal symptom burden and quality of life.