补充 3 个月合生素对新冠后慢性疲劳综合征成年患者患者报告结局、运动耐量以及大脑和肌肉代谢的影响（STOP-FATIGUE）：一项随机安慰剂对照临床试验。

The effects of 3-month supplementation with synbiotic on patient-reported outcomes, exercise tolerance, and brain and muscle metabolism in adult patients with post-COVID-19 chronic fatigue syndrome (STOP-FATIGUE): a randomized Placebo-controlled clinical trial.

机构信息

Applied Bioenergetics Lab, Faculty of Sport and PE, University of Novi Sad, Novi Sad, Serbia.

Faculty of Medicine, University of Novi Sad, Novi Sad, Serbia.

出版信息

Eur J Nutr. 2024 Nov 26;64(1):28. doi: 10.1007/s00394-024-03546-0.

DOI:10.1007/s00394-024-03546-0

PMID:39592468

Abstract

PURPOSE

Considering the observed gastrointestinal issues linked to post-COVID-19 myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), beneficially modulating the gut microbiota could offer a safe, cost-effective nutritional strategy. This trial aimed to evaluate the effects of medium-term synbiotic supplementation on patient-reported outcomes, exercise tolerance, and tissue metabolism in patients with post-COVID-19 ME/CFS.

METHODS

Between September 2022 and December 2023, we investigated the impact of 3-month supplementation with a synbiotic mixture including L. rhamnosus DSM 32550, Humiome® L. plantarum DSM 34532, B. lactis DSM 32269, B. longum DSM 32946, fructooligosaccharides and zinc, on predetermined primary and secondary outcome measures in twenty six post-COVID-19 ME/CFS patients utilizing a parallel-group, randomized, placebo-controlled, double-blind design.

RESULTS

Both the synbiotic and placebo intake resulted in a significant reduction in general fatigue after 3 months compared to the baseline values (P ≤ 0.05). This was accompanied by a significant interaction effect (time vs. treatment) for post-exercise malaise (P = 0.02), with synbiotic superior to placebo to attenuate post-exercise malaise. The synbiotic also demonstrated a significant advantage over placebo in increasing choline levels at the thalamus (P = 0.02), and creatine levels at left frontal white matter (P = 0.05) and left frontal grey matter (P = 0.04).

CONCLUSION

Taking the synbiotic mixture for three months improves tissue metabolism and mitigates clinical features of post-COVID-19 fatigue syndrome. The presented data show promise in addressing the widespread issue of ME/CFS following the COVID-19 pandemic; however, further validation is needed before endorsing the synbiotics within this clinical context. The study is registered at ClinicalTrials.gov (NCT06013072).

摘要

目的

鉴于与 post-COVID-19 肌痛性脑脊髓炎/慢性疲劳综合征（ME/CFS）相关的胃肠道问题，有益地调节肠道微生物群可能提供一种安全、具有成本效益的营养策略。本试验旨在评估中期联合补充益生菌对 post-COVID-19 ME/CFS 患者患者报告结果、运动耐量和组织代谢的影响。

方法

在 2022 年 9 月至 2023 年 12 月期间，我们使用平行组、随机、安慰剂对照、双盲设计，调查了 3 个月联合补充包括 L. rhamnosus DSM 32550、Humiome® L. plantarum DSM 34532、B. lactis DSM 32269、B. longum DSM 32946、低聚果糖和锌的益生菌混合物对 26 名 post-COVID-19 ME/CFS 患者预定的主要和次要终点的影响。

结果

与基线值相比，联合补充益生菌和安慰剂均可在 3 个月后显著降低全身疲劳（P≤0.05）。这伴随着运动后不适的显著交互效应（时间与治疗）（P=0.02），联合补充益生菌比安慰剂更能减轻运动后不适。联合补充益生菌也显著优于安慰剂，增加丘脑胆碱水平（P=0.02），左额叶白质（P=0.05）和左额叶灰质（P=0.04）肌酸水平。

结论

连续服用 3 个月益生菌混合物可改善组织代谢，减轻 post-COVID-19 疲劳综合征的临床特征。所提供的数据表明，在解决 post-COVID-19 大流行后广泛存在的 ME/CFS 问题方面具有前景；然而，在这种临床环境中认可益生菌还需要进一步验证。该研究在 ClinicalTrials.gov（NCT06013072）注册。