Probiotics and prebiotic fiber for constipation associated with Parkinson disease

Michela Barichella, Claudio Pacchetti, Carlotta Bolliri, Erica Cassani, Laura Iorio, Chiara Pusani, Giovanna Pinelli, Giulia Privitera, Ilaria Cesari, Samanta Andrea Faierman, Riccardo Caccialanza, Gianni Pezzoli, Emanuele Cereda

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Abstract

Objectives: Our objective was to evaluate the efficacy of probiotics and prebiotics in patients with Parkinson disease (PD) and constipation. Methods: We conducted a tertiary setting, randomized, double-blind, placebo-controlled trial in patients with PD with Rome III-confirmed constipation based on 2-week stool diary data at baseline. Patients (n 120) were randomly assigned (2:1) to either a fermented milk, containing multiple probiotic strains and prebiotic fiber, or placebo, once daily for 4 weeks. The primary efficacy endpoint was the increase in the number of complete bowel movements (CBMs) per week. The key secondary endpoints were 3 or more CBMs and an increase by one or more CBMs per week during weeks 3 and 4. Results: For the primary endpoint, the consumption of a fermented milk containing probiotics and prebiotics resulted in a higher increase in the number of CBMs (mean 1.2, 95% confidence interval [CI] 0.8-1.6) than placebo (0.1, 95% CI -0.4% to 0.6%) (mean difference 1.1, 95% CI 0.4-1.8; p 0.002). For the key secondary endpoints, a higher number of patients in the probiotics-prebiotics group vs the placebo group reported 3 or more CBMs (p 0.030; 58.8% vs 37.5%; odds ratio 2.4, 95% CI 1.1-5.2) and an increase by one or more CBMs (p 0.004; 53.8% vs 25.0%; odds ratio 3.5, 95% CI 1.8-8.1) during weeks 3 and 4. Conclusions: The consumption of a fermented milk containing multiple probiotic strains and prebiotic fiber was superior to placebo in improving constipation in patients with PD. ClinicalTrials.gov identifier: NCT02459717. Classification of evidence: This study provides Class I evidence that for patients with PD who have constipation, fermented milk containing probiotics and prebiotics increases the frequency of CBMs.

Original languageEnglish
Pages (from-to)1274-1280
Number of pages7
JournalNeurology
Volume87
Issue number12
DOIs
Publication statusPublished - Sep 20 2016

ASJC Scopus subject areas

  • Clinical Neurology

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  • Cite this

    Barichella, M., Pacchetti, C., Bolliri, C., Cassani, E., Iorio, L., Pusani, C., Pinelli, G., Privitera, G., Cesari, I., Faierman, S. A., Caccialanza, R., Pezzoli, G., & Cereda, E. (2016). Probiotics and prebiotic fiber for constipation associated with Parkinson disease. Neurology, 87(12), 1274-1280. https://doi.org/10.1212/WNL.0000000000003127