Objective: To investigate the effects of probiotics on constipation in PD, using a randomized controlled trial (RCT) design

Background: Non-motor symptoms (NMS) cause significant disability and impairment of quality of life among patients with Parkinson’s disease (PD). Although constipation is the most common gastrointestinal symptom, affecting up to 70% of patients with PD, there are few RCTS assessing the efficacy of treatments for constipation in PD

Methods: This is a randomized, double-blind, parallel-group, placebo-controlled RCT. PD patients who fulfil ROME IV Criteria for functional constipation are recruited consecutively and randomized to receive either 4 weeks of probiotic capsules containing strains of Bifidobacterium, Lactobacillus and Enterococcus; or identical-appearing placebo capsules containing (inactive) maltodextrin. Data are collected on patient demographics, clinical status (including MDS-UPDRS), body mass index, medications, dietary intake, and physical activity (SIMPAQ). The primary outcome measure is the change in the average number of spontaneous bowel movements during the last 2 weeks of intervention compared to the 2-week pretreatment phase, as recorded by stool diary. Secondary outcome measures include changes in the constipation severity scale (adapted from ROME IV criteria), average stool consistency (Bristol stool scale), and quality of life scale related to constipation (PAC-QOL). Any adverse effects are recorded.

Results: Sample size calculation revealed that 36 patients are required in each arm at 1:1 ratio (total 72 patients) to achieve clinical superiority with alpha of 0.05 and power of 0.80. To date, 40 patients have been recruited, with mean age 69 ± 6.7 years, disease duration 8.5 ± 5.4 years, Hoehn and Yahr score 1.9 ± 0.7, and total MDS-UPDRS score 64.5 ± 22.2. Average stool frequency per week at baseline was 3.8 ± 1.5 and average stool consistency was 5.0 ± 1.5 (range:1-7, higher scores indicating harder stools). Mean constipation severity score was 8.3 ± 2.6 (range:0-15, higher scores indicating worse severity) and total PAC-QOL score was 67.3 ± 19.9 (range:28-140, higher scores indicating poorer quality of life).

Conclusions: This is an ongoing study to determine whether probiotics are effective in relieving constipation in PD patients. To date, patient enrollment and retention in the study have been satisfactory, with no unexpected adverse events reported.

References: 1.Barichella M, Paccheti C, Bolliri C, et al. Probiotics and prebiotic fiber for constipation associated with Parkinson disease – An RCT. Neurology 2016; 87:1274-1280. 2.Cassani E, Privitera G, Pezzoli G, et al. Use of probiotics for the treatment of constipation in Parkinson’s disease patients. Minerva Gastroenterol Dietol. 2011;57:117-21.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/a-randomized-double-blind-placebo-controlled-trial-of-probiotics-for-constipation-in-parkinsons-disease/