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双相情感障碍或精神分裂症谱系障碍患者的益生菌制剂:一项双盲、随机、安慰剂对照试验。

Probiotic Formulation for Patients With Bipolar or Schizophrenia Spectrum Disorder: A Double-Blind, Randomized Placebo-Controlled Trial.

作者信息

Borkent Jenny, Ioannou Magdalini, Neijzen Dorien, Haarman Bartholomeus C M, Sommer Iris E C

机构信息

Department of Biomedical Sciences, University Medical Center Groningen, University of Groningen, 9713 GZ, Groningen, The Netherlands.

Department of Psychiatry, University Medical Center Groningen, University of Groningen, 9713 GZ, Groningen, The Netherlands.

出版信息

Schizophr Bull. 2024 Nov 6. doi: 10.1093/schbul/sbae188.

DOI:10.1093/schbul/sbae188
PMID:39504580
Abstract

BACKGROUND AND HYPOTHESIS

Probiotic augmentation offers a promising treatment for bipolar disorder (BD) and schizophrenia spectrum disorder (SSD). By targeting microbiome deviations, they may improve both gut and brain health.

STUDY DESIGN

In this double-blind, randomized, placebo-controlled trial with the multi-strain probiotic formulation Ecologic BARRIER, we aimed to improve psychiatric and cognitive symptoms, intestinal permeability, and gastrointestinal symptoms in patients with BD or SSD. A total of 131 patients were randomized 1:1 to receive either the probiotic supplement (n = 67) or a placebo (n = 64) for 3 months, in addition to treatment-as-usual. The primary outcomes were symptom severity assessed by the Brief Psychiatric Rating Scale and cognitive functioning by the Brief Assessment of Cognition in Schizophrenia.

STUDY RESULTS

No significant effect of probiotics was observed on psychiatric symptoms, but borderline significant improvement was observed in the cognition category of verbal memory (Linear Mixed Model (LMM) 0.33; adjusted P = .059). Probiotics beneficially affected markers of intestinal permeability and inflammation, including zonulin (LMMserum = -18.40; adjusted P = .002; LMMfecal = -10.47; adjusted P = .014) and alpha-1 antitrypsin (LMM 9.26; adjusted P = .025). Indigestion complaints significantly decreased in male participants in the probiotics group (LMM = -0.70; adjusted P = .010). Adverse events were similar between groups.

CONCLUSIONS

Our study observed significant advantages of probiotics for gut health in BD and SSD, with excellent safety and tolerability. A borderline effect on verbal memory was also indicated. These results underscore the need for further research into microbiome-targeted interventions for patients with complex brain disorders.

摘要

背景与假设

益生菌补充疗法为双相情感障碍(BD)和精神分裂症谱系障碍(SSD)提供了一种有前景的治疗方法。通过针对微生物群偏差,它们可能改善肠道和大脑健康。

研究设计

在这项使用多菌株益生菌制剂Ecologic BARRIER的双盲、随机、安慰剂对照试验中,我们旨在改善BD或SSD患者的精神和认知症状、肠道通透性及胃肠道症状。总共131名患者按1:1随机分组,除常规治疗外,分别接受益生菌补充剂(n = 67)或安慰剂(n = 64)治疗3个月。主要结局是通过简明精神病评定量表评估的症状严重程度以及通过精神分裂症认知简要评估来评估的认知功能。

研究结果

未观察到益生菌对精神症状有显著影响,但在言语记忆的认知类别中观察到临界显著改善(线性混合模型(LMM)0.33;校正P = 0.059)。益生菌对肠道通透性和炎症标志物有有益影响,包括闭合蛋白(LMM血清=-18.40;校正P = 0.002;LMM粪便=-10.47;校正P = 0.014)和α-1抗胰蛋白酶(LMM 9.26;校正P = 0.025)。益生菌组男性参与者的消化不良症状显著减少(LMM=-0.70;校正P = 0.010)。两组间不良事件相似。

结论

我们的研究观察到益生菌对BD和SSD患者的肠道健康有显著优势,具有良好的安全性和耐受性。还表明对言语记忆有临界效应。这些结果强调了对复杂脑部疾病患者进行微生物群靶向干预的进一步研究的必要性。

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