Abstract
Objective To evaluate the effect of a prebiotic derived from kiwifruit (Livaux®) on constipation and gut microbiome constituents in patients with Parkinson’s disease (PD).
Methods Patients with PD and functional constipation were eligible and kept stool diaries for at least 4 weeks and 3-day fluid and food diaries to ensure adeqaute hydration and fiber intake before enrollment. Patients took Livaux 2400mg or matching placebo daily for 6 weeks with a washout period of at least 4 weeks between treatment periods. Patients completed bowel diaries, a Patient Assessment of Constipation Symptoms (PAC-Sym) questionnaire and took radio-opaque pellets daily during the 6th week of a treatment period followed by an abdominal x-ray to estimate colonic transit time. Stool, blood and serum biomarker samples were collected at the beginning and end of each treatment period to assess bacterial populations, microbiome metabolites and other biomarkers. Completed Bowel Motions (CBM)/week was the primary end-point. Secondary endpoints included total, spontaneous and complete spontaneous BM, PAC-Sym score and colonic transit time.
Results Twelve patients were randomised equally to start Livaux or placebo. There was no significant difference in CBM/week between Livaux and placebo treatment periods (2.2 v 2.2, difference 0.0, 95% CI -0.7 to 0.8, p=0.9). Of the secondary endpoints only spontaneous BM differed with more in the Livaux group (3.8 v 3.3, difference 0.5, 95%CI 0.0 to 1.0, p=0.047). There were no significant adverse events.
Conclusion Treatment with Livaux, although well tolerated, did not clearly improve constipation in subjects with PD in this study.
