Michela Barichella1, Claudio Pacchetti1, Carlotta Bolliri1, Erica Cassani1, Laura Iorio1, Chiara Pusani1, Giovanna Pinelli1, Giulia Privitera1, Ilaria Cesari1, Samanta Andrea Faierman1, Riccardo Caccialanza1, Gianni Pezzoli1, Emanuele Cereda2. 1. 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. 2. 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.
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. CLINICALTRIALSGOV 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.
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. CLINICALTRIALSGOV 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.
Authors: Zachary D Wallen; Mary Appah; Marissa N Dean; Cheryl L Sesler; Stewart A Factor; Eric Molho; Cyrus P Zabetian; David G Standaert; Haydeh Payami Journal: NPJ Parkinsons Dis Date: 2020-06-12
Authors: Madelyn C Houser; Jianjun Chang; Stewart A Factor; Eric S Molho; Cyrus P Zabetian; Erin M Hill-Burns; Haydeh Payami; Vicki S Hertzberg; Malú G Tansey Journal: Mov Disord Date: 2018-03-23 Impact factor: 10.338