Evidence map›Paper›PMID 39592468›Full record

Trial reportEuropean journal of nutrition2024

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.

Marijana Ranisavljev, Valdemar Stajer, Nikola Todorovic, Jelena Ostojic, Jelena Helena Cvejic, Robert E Steinert, Sergej M Ostojic

Erratum issued Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in European journal of nutrition, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT06013072 (The Effects of 3-month Supplementation With a Pre-probiotic on Patient- and Clinician-reported Outcomes, and Brain Tissue Metabolism in Patients With Post-covid Fatigue Syndrome), which is not on this map. Cited by 13 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 3 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06013072 nacompletednot on this map

The Effects of 3-month Supplementation With a Pre-probiotic on Patient- and Clinician-reported Outcomes, and Brain Tissue Metabolism in Patients With Post-covid Fatigue Syndrome: a Placebo-controlled Randomized Clinical Trial

TypeinterventionalSponsorUniversity of Novi Sad, Faculty of Sport and Physical EducationRan2022 to 2024Enrolled32ConditionsLong COVIDArmsDietary Supplement: Experimental, Dietary Supplement: Placebo
3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Guideline
  2. Pooled it
  3. Pooled it
  4. Review
  5. Article
  6. Review
  7. Article
  8. Review
  9. Microbiome and Long COVID-19: Current Evidence and Insights.International journal of molecular sciences · 2025
    Review
  10. Creatine and post-viral fatigue syndrome: an update.Journal of the International Society of Sports Nutrition · 2025
    Review
  11. Article
  12. Article
  13. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

7 authors.

Marijana RanisavljevApplied Bioenergetics Lab, Faculty of Sport and PE, University of Novi Sad, Novi Sad, Serbia.
Valdemar StajerApplied Bioenergetics Lab, Faculty of Sport and PE, University of Novi Sad, Novi Sad, Serbia.
Nikola TodorovicApplied Bioenergetics Lab, Faculty of Sport and PE, University of Novi Sad, Novi Sad, Serbia.
Jelena OstojicApplied Bioenergetics Lab, Faculty of Sport and PE, University of Novi Sad, Novi Sad, Serbia.
Jelena Helena CvejicApplied Bioenergetics Lab, Faculty of Sport and PE, University of Novi Sad, Novi Sad, Serbia.
Robert E SteinertDSM-Firmenich, Health, Nutrition & Care (HNC), Kaiseraugst, Switzerland.
Sergej M OstojicApplied Bioenergetics Lab, Faculty of Sport and PE, University of Novi Sad, Novi Sad, Serbia. sergej.ostojic@chess.edu.rs.ORCID http://orcid.org/0000-0002-7270-2541

Funding

Provincial Secretariat for Higher Education and Scientific Research 142-451-2597/2021-01
6 · The paper itself

Abstract

purposeConsidering 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.

methodsBetween 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.

resultsBoth 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).

conclusionTaking 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).

Indexed as

COVID-19Dietary SupplementsExercise ToleranceFatigue Syndrome, ChronicSynbioticsAdultBrainDouble-Blind MethodFemaleGastrointestinal MicrobiomeHumansMaleMiddle AgedMuscle, SkeletalPatient Reported Outcome MeasuresPost-Acute COVID-19 SyndromeBrain metabolismChronic fatigue syndromePost-exercise malaiseProbiotics

Identifiers

PMID39592468

What OpenQuestion holds

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Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.