Abstract

Background:

Probiotics use has been associated with modulation of inflammation and considered as a possible intervention for CNS diseases such as mild cognitive impairment (MCI) and dementia.

Objective:

We aimed to test the effect of the probiotic strain, Bifidobacterium breve A1 (MCC1274), to restore cognition in a physically healthy, suspected MCI population.

Methods:

In this randomized, double-blind, placebo-controlled trial, 80 healthy older adults suffering from MCI were divided into two even groups to receive once daily either probiotic (B. breve A1, 2×10¹⁰ CFU) or placebo for 16 weeks using a computer-generated algorithm. Cognitive functions were assessed by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) and the Japanese version of the MCI Screen (JMCIS) tests before and after the study as primary and secondary endpoints, respectively.

Results:

79 participants completed the study, and no adverse events were observed. RBANS total score was significantly improved in probiotic group compared with placebo (mean between-group difference 11.3 [95% CI 6.7 to 15.8]; p < 0.0001) after 16 weeks of consumption, in particular with significant improvement in domain scores of immediate memory, visuospatial/constructional, and delayed memory (p < 0.0001), in both intention-to-treat (ITT) analysis and per-protocol (PP) analysis. JMCIS score was also improved versus placebo in ITT analysis (p = 0.052) and PP analysis (p = 0.036).

Conclusion:

Study results indicate B. breve A1 is a safe and effective approach for improving memory functions of suspected MCI subjects.

中文翻译：

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益生菌短双歧杆菌可改善疑似轻度认知障碍的老年人的认知功能：一项随机、双盲、安慰剂对照试验。

摘要

背景：

益生菌的使用与炎症调节有关，并被认为是对轻度认知障碍 (MCI) 和痴呆等中枢神经系统疾病的可能干预措施。

客观的：

我们的目的是测试益生菌菌株短双歧杆菌A1 (MCC1274) 在身体健康、疑似 MCI 人群中恢复认知能力的效果。

方法：

在这项随机、双盲、安慰剂对照试验中，80 名患有 MCI 的健康老年人被分为两组，每天接受一次益生菌（短双歧杆菌A1，2×10 ¹⁰ CFU）或安慰剂，持续 16 周。计算机生成的算法。在研究之前和之后分别通过神经心理状态评估的可重复电池组 (RBANS) 和日本版 MCI 筛查 (JMCIS) 测试来评估认知功能作为主要和次要终点。

结果：

79 名参与者完成了研究，没有观察到不良事件。 服用 16 周后，与安慰剂组相比，益生菌组的 RBANS 总分显着提高（平均组间差异 11.3 [95% CI 6.7 至 15.8]；p < 0.0001），特别是即时记忆领域得分显着改善， 在意向治疗 (ITT) 分析和符合方案 (PP) 分析中，视觉空间/结构性和延迟记忆 ( p < 0.0001)。在 ITT 分析 ( p  = 0.052) 和 PP 分析 ( p = 0.036)中，JMCIS 评分也比安慰剂有所改善 。

结论：

研究结果表明，短双歧杆菌A1 是改善疑似 MCI 受试者记忆功能的安全有效方法。