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September 20, 2016; 87 (12) Article

Probiotics and prebiotic fiber for constipation associated with Parkinson disease

An RCT

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
First published August 19, 2016, DOI: https://doi.org/10.1212/WNL.0000000000003127
Michela Barichella
From the Parkinson Institute (M.B., C.B., E. Cassani, L.I., C. Pusani, G. Pinelli, G. Privitera, I.C., S.A.F., G. Pezzoli), ASST G. Pini-CTO, ex ICP, Milan; Parkinson and Movement Disorders Unit (C. Pacchetti), IRCCS Istituto Neurologico Mondino, Pavia; and Nutrition and Dietetics Service (R.C., E. Cereda), Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.
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Claudio Pacchetti
From the Parkinson Institute (M.B., C.B., E. Cassani, L.I., C. Pusani, G. Pinelli, G. Privitera, I.C., S.A.F., G. Pezzoli), ASST G. Pini-CTO, ex ICP, Milan; Parkinson and Movement Disorders Unit (C. Pacchetti), IRCCS Istituto Neurologico Mondino, Pavia; and Nutrition and Dietetics Service (R.C., E. Cereda), Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.
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Carlotta Bolliri
From the Parkinson Institute (M.B., C.B., E. Cassani, L.I., C. Pusani, G. Pinelli, G. Privitera, I.C., S.A.F., G. Pezzoli), ASST G. Pini-CTO, ex ICP, Milan; Parkinson and Movement Disorders Unit (C. Pacchetti), IRCCS Istituto Neurologico Mondino, Pavia; and Nutrition and Dietetics Service (R.C., E. Cereda), Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.
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Erica Cassani
From the Parkinson Institute (M.B., C.B., E. Cassani, L.I., C. Pusani, G. Pinelli, G. Privitera, I.C., S.A.F., G. Pezzoli), ASST G. Pini-CTO, ex ICP, Milan; Parkinson and Movement Disorders Unit (C. Pacchetti), IRCCS Istituto Neurologico Mondino, Pavia; and Nutrition and Dietetics Service (R.C., E. Cereda), Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.
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Laura Iorio
From the Parkinson Institute (M.B., C.B., E. Cassani, L.I., C. Pusani, G. Pinelli, G. Privitera, I.C., S.A.F., G. Pezzoli), ASST G. Pini-CTO, ex ICP, Milan; Parkinson and Movement Disorders Unit (C. Pacchetti), IRCCS Istituto Neurologico Mondino, Pavia; and Nutrition and Dietetics Service (R.C., E. Cereda), Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.
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Chiara Pusani
From the Parkinson Institute (M.B., C.B., E. Cassani, L.I., C. Pusani, G. Pinelli, G. Privitera, I.C., S.A.F., G. Pezzoli), ASST G. Pini-CTO, ex ICP, Milan; Parkinson and Movement Disorders Unit (C. Pacchetti), IRCCS Istituto Neurologico Mondino, Pavia; and Nutrition and Dietetics Service (R.C., E. Cereda), Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.
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Giovanna Pinelli
From the Parkinson Institute (M.B., C.B., E. Cassani, L.I., C. Pusani, G. Pinelli, G. Privitera, I.C., S.A.F., G. Pezzoli), ASST G. Pini-CTO, ex ICP, Milan; Parkinson and Movement Disorders Unit (C. Pacchetti), IRCCS Istituto Neurologico Mondino, Pavia; and Nutrition and Dietetics Service (R.C., E. Cereda), Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.
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Giulia Privitera
From the Parkinson Institute (M.B., C.B., E. Cassani, L.I., C. Pusani, G. Pinelli, G. Privitera, I.C., S.A.F., G. Pezzoli), ASST G. Pini-CTO, ex ICP, Milan; Parkinson and Movement Disorders Unit (C. Pacchetti), IRCCS Istituto Neurologico Mondino, Pavia; and Nutrition and Dietetics Service (R.C., E. Cereda), Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.
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Ilaria Cesari
From the Parkinson Institute (M.B., C.B., E. Cassani, L.I., C. Pusani, G. Pinelli, G. Privitera, I.C., S.A.F., G. Pezzoli), ASST G. Pini-CTO, ex ICP, Milan; Parkinson and Movement Disorders Unit (C. Pacchetti), IRCCS Istituto Neurologico Mondino, Pavia; and Nutrition and Dietetics Service (R.C., E. Cereda), Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.
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Samanta Andrea Faierman
From the Parkinson Institute (M.B., C.B., E. Cassani, L.I., C. Pusani, G. Pinelli, G. Privitera, I.C., S.A.F., G. Pezzoli), ASST G. Pini-CTO, ex ICP, Milan; Parkinson and Movement Disorders Unit (C. Pacchetti), IRCCS Istituto Neurologico Mondino, Pavia; and Nutrition and Dietetics Service (R.C., E. Cereda), Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.
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Riccardo Caccialanza
From the Parkinson Institute (M.B., C.B., E. Cassani, L.I., C. Pusani, G. Pinelli, G. Privitera, I.C., S.A.F., G. Pezzoli), ASST G. Pini-CTO, ex ICP, Milan; Parkinson and Movement Disorders Unit (C. Pacchetti), IRCCS Istituto Neurologico Mondino, Pavia; and Nutrition and Dietetics Service (R.C., E. Cereda), Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.
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Gianni Pezzoli
From the Parkinson Institute (M.B., C.B., E. Cassani, L.I., C. Pusani, G. Pinelli, G. Privitera, I.C., S.A.F., G. Pezzoli), ASST G. Pini-CTO, ex ICP, Milan; Parkinson and Movement Disorders Unit (C. Pacchetti), IRCCS Istituto Neurologico Mondino, Pavia; and Nutrition and Dietetics Service (R.C., E. Cereda), Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.
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Emanuele Cereda
From the Parkinson Institute (M.B., C.B., E. Cassani, L.I., C. Pusani, G. Pinelli, G. Privitera, I.C., S.A.F., G. Pezzoli), ASST G. Pini-CTO, ex ICP, Milan; Parkinson and Movement Disorders Unit (C. Pacchetti), IRCCS Istituto Neurologico Mondino, Pavia; and Nutrition and Dietetics Service (R.C., E. Cereda), Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.
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Citation
Probiotics and prebiotic fiber for constipation associated with Parkinson disease
An RCT
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
Neurology Sep 2016, 87 (12) 1274-1280; DOI: 10.1212/WNL.0000000000003127

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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.

GLOSSARY

BM=
bowel movement;
CBM=
complete bowel movement;
CI=
confidence interval;
PD=
Parkinson disease

Footnotes

  • Go to Neurology.org for full disclosures. Funding information and disclosures deemed relevant by the authors, if any, are provided at the end of the article.

  • Received February 19, 2016.
  • Accepted in final form June 8, 2016.
  • © 2016 American Academy of Neurology
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