Barichella Michela, Pacchetti Claudio, Bolliri Carlotta, Cassani Erica, Iorio Laura, Pusani Chiara, Pinelli Giovanna, Privitera Giulia, Cesari Ilaria, Faierman Samanta Andrea, Caccialanza Riccardo, Pezzoli Gianni, Cereda Emanuele
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.
Neurology. 2016 Sep 20;87(12):1274-80. doi: 10.1212/WNL.0000000000003127. Epub 2016 Aug 19.
Our objective was to evaluate the efficacy of probiotics and prebiotics in patients with Parkinson disease (PD) and constipation.
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.
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.
The consumption of a fermented milk containing multiple probiotic strains and prebiotic fiber was superior to placebo in improving constipation in patients with PD.
NCT02459717.
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.
我们的目的是评估益生菌和益生元对帕金森病（PD）合并便秘患者的疗效。
我们在一家三级医疗机构进行了一项随机、双盲、安慰剂对照试验，研究对象为根据基线时2周的粪便日记数据确诊为罗马III型便秘的PD患者。患者（n = 120）被随机分配（2:1）至每日服用一次含多种益生菌菌株和益生元纤维的发酵乳组或安慰剂组，为期4周。主要疗效终点是每周完全自主排便次数（CBMs）的增加。关键次要终点是在第3周和第4周期间每周有3次或更多次CBMs以及每周CBMs增加1次或更多次。
对于主要终点，服用含益生菌和益生元纤维的发酵乳导致CBMs数量增加幅度更大（平均增加1.2次，95%置信区间[CI] 0.8 - 1.6），高于安慰剂组（0.1次，95% CI -0.4%至0.6%）（平均差异1.1，95% CI 0.4 - 1.8；p = 0.002）。对于关键次要终点，益生菌 - 益生元组中报告每周有3次或更多次CBMs的患者数量高于安慰剂组（p = 0.030；58.8%对37.5%；优势比 = 2.4，95% CI 1.1 - 5.2），且在第3周和第4周期间每周CBMs增加1次或更多次的患者数量也高于安慰剂组（p = 0.004；53.8%对25.0%；优势比 = 3.5，95% CI 1.8 - 8.1）。
服用含多种益生菌菌株和益生元纤维的发酵乳在改善PD患者便秘方面优于安慰剂。
NCT02459717。
本研究提供I级证据，表明对于合并便秘的PD患者，含益生菌和益生元纤维的发酵乳可增加CBMs的频率。
