Probiotics for constipation in Parkinson’s disease: A randomized placebo-controlled study

Abstract

Objective:To determine whether probiotics are effective for constipation, a common and often difficult-to-treat problem, in Parkinson’s disease (PD).Methods:In this double-blind, randomized placebo-controlled single-centre trial, 280 PD patients were screened and 72 eligible patients were block-randomized (1:1) to receive either multi-strain probiotics capsules (n=34), or identical-appearing placebo (n=38), for four weeks. The primary endpoint was the change in the average number of spontaneous bowel movements (SBM) per week during the last two weeks of intervention, compared with the two-week pre-intervention phase, recorded by daily stool diary. Secondary outcome measures included changes in stool consistency, constipation severity score, and quality of life related to constipation. Satisfaction with intervention received was assessed. Change in levels of fecal calprotectin, a marker of intestinal inflammation, was an exploratory outcome.Results:SBM increased by 1.0±1.2/week after treatment with probiotics, and decreased by 0.3±1.0/week in the placebo group (mean difference 1.3, 95%CI: 0.8-1.8, P<0.001). Significant improvements were also seen for secondary outcomes after correction for multiple comparisons, including stool consistency (P=0.009) and quality of life related to constipation (P=0.001). In the treatment group, 65.6% reported satisfaction with the intervention, vs. only 21.6% in the placebo group (P<0.001). One patient (2.9%) in the treatment group withdrew due to a non-serious adverse event. Fecal calprotectin did not change significantly during the study.Conclusions:Multi-strain probiotics treatment was effective for constipation in PD. Further studies are needed to investigate the long-term efficacy and safety of probiotics in PD, as well as their mechanisms of action.Classification of evidence:This study provides Class I evidence that for people with PD, multi-strain probiotics significantly increased the average number of spontaneous bowel movements per week.Clinicaltrials.gov identifier:NCT03377322