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

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

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).

Keywords: Brain metabolism; Chronic fatigue syndrome; Post-exercise malaise; Probiotics.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Brain / metabolism
  • COVID-19* / complications
  • COVID-19* / metabolism
  • COVID-19* / therapy
  • Dietary Supplements*
  • Double-Blind Method
  • Exercise Tolerance* / drug effects
  • Exercise Tolerance* / physiology
  • Fatigue Syndrome, Chronic* / diet therapy
  • Fatigue Syndrome, Chronic* / metabolism
  • Fatigue Syndrome, Chronic* / therapy
  • Female
  • Gastrointestinal Microbiome / physiology
  • Humans
  • Male
  • Middle Aged
  • Muscle, Skeletal / drug effects
  • Muscle, Skeletal / metabolism
  • Patient Reported Outcome Measures
  • Post-Acute COVID-19 Syndrome
  • SARS-CoV-2
  • Synbiotics* / administration & dosage

Associated data

  • ClinicalTrials.gov/NCT06013072