title: Probiotics and prebiotic fiber for constipation associated with Parkinson disease: An RCT.
abstract: OBJECTIVE
  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.
  
  
  BACKGROUND
  NCT02459717.
  
  
  METHODS
  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.
authors.affiliation: 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.
authors.forename: Michela
authors.initials: M
authors.lastname: Barichella
authors.affiliation: 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.
authors.forename: Claudio
authors.initials: C
authors.lastname: Pacchetti
authors.affiliation: 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.
authors.forename: Carlotta
authors.initials: C
authors.lastname: Bolliri
authors.affiliation: 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.
authors.forename: Erica
authors.initials: E
authors.lastname: Cassani
authors.affiliation: 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.
authors.forename: Laura
authors.initials: L
authors.lastname: Iorio
authors.affiliation: 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.
authors.forename: Chiara
authors.initials: C
authors.lastname: Pusani
authors.affiliation: 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.
authors.forename: Giovanna
authors.initials: G
authors.lastname: Pinelli
authors.affiliation: 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.
authors.forename: Giulia
authors.initials: G
authors.lastname: Privitera
authors.affiliation: 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.
authors.forename: Ilaria
authors.initials: I
authors.lastname: Cesari
authors.affiliation: 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.
authors.forename: Samanta Andrea
authors.initials: SA
authors.lastname: Faierman
authors.affiliation: 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.
authors.forename: Riccardo
authors.initials: R
authors.lastname: Caccialanza
authors.affiliation: 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.
authors.forename: Gianni
authors.initials: G
authors.lastname: Pezzoli
authors.affiliation: 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. e.cereda@smatteo.pv.it.
authors.forename: Emanuele
authors.initials: E
authors.lastname: Cereda
mesh_terms: D000368:Aged; D000818:Animals; D003248:Constipation / Q000178:diet therapy* / Q000209:etiology; D003672:Defecation; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008892:Milk; D010045:Outpatients; D010300:Parkinson Disease / Q000150:complications* / Q000178:diet therapy*; D017060:Patient Satisfaction; D056692:Prebiotics / Q000008:administration & dosage* / Q000009:adverse effects; D019936:Probiotics / Q000008:administration & dosage* / Q000009:adverse effects; D012720:Severity of Illness Index; D062606:Tertiary Care Centers; D016896:Treatment Outcome
chemical_list: D056692:Prebiotics