Trial Report The effects of 3-month supplementation with synbiotic ... in adult patients with post-COVID-19 CFS (STOP-FATIGUE), 2024, Ranisavljev

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https://link.springer.com/article/10.1007/s00394-024-03546-0

Ranisavljev, M., Stajer, V., Todorovic, N. et al. 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 64, 28 (2025). https://doi.org/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).

 
Clinical trial examines effects of synbiotic blend for post-COVID-19 chronic fatigue syndrome
In a recent press release, dsm-firmenich announced results from a clinical trial examining the effects of synbiotics on post-COVID-19 chronic fatigue syndrome (CFS). Symptoms of the condition include general fatigue, post-exercise malaise, and poor sleep. As the press release explained, CFS can also result from high stress or from other viral or bacterial infections. The clinical trial1, “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,” was published in the European Journal of Nutrition.

The three-month study involved 26 post-COVID participants who were given either a placebo or a mix of synbiotics. The synbiotic blend used contained L. rhamnosus DSM 32550, Humiome L. plantarum DSM 34532, B. lactis DSM 32269, B. longum DSM 32946, fructooligosaccharides, and zinc. Proton magnetic resonance spectroscopy was also used to measure changes in brain metabolites.

Highlighted results include:

  • Both groups demonstrated a reduction in general fatigue compared to baseline, though the synbiotic blend demonstrated greater decrease in post-exercise malaise
  • Increased choline levels in the thalamus along with creatine levels at left frontal white matter and left frontal grey matter were seen in the synbiotic group more consistently than in the placebo group
Ultimately, the supplementation was found to improve tissue metabolism and mitigate clinical features.

“This study offers compelling new evidence that targeted synbiotic supplementation to restore gut microbiota can positively influence brain energy metabolism and can reduce hallmark symptoms of post-viral fatigue syndromes like CFS,” stated Robert E. Steinert, HNC Principal Scientist at dsm-firmenich, in the press release. “Chronic fatigue is a debilitating condition that can severely impact quality of life for those affected by it, with this research marking an important step forward in demonstrating the potential of synbiotics in managing CFS symptoms. It opens the door for greater innovation in development of nutritional supplements and solutions that can provide both a physical and metaphorical boost for CFS patients.”
https://www.nutritionaloutlook.com/...nd-for-post-covid-19-chronic-fatigue-syndrome
 
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