Evidence map›Paper›PMID 29409505›Full record

Trial reportJournal of translational medicine2018

Open-label pilot for treatment targeting gut dysbiosis in myalgic encephalomyelitis/chronic fatigue syndrome: neuropsychological symptoms and sex comparisons.

Amy Wallis, Michelle Ball, Henry Butt, Donald P Lewis, Sandra McKechnie, Phillip Paull, Amber Jaa-Kwee, Dorothy Bruck

Erratum issuedOpen access · goldAbstract readClinical TrialComparative Study
In one paragraph

Trial report in Journal of translational medicine, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 24 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 1 pooled it
1.6field-weighted citation impact, top 17% of its field
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

24 citing papers in PubMed, 1 synthesis or guideline pooled it, 35 citations in OpenAlex.

  1. Recent research in myalgic encephalomyelitis/chronic fatigue syndrome: an evidence map.Health technology assessment (Winchester, England) · 2025
    Pooled it
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  20. Gut microbiota and fatigue in rectal cancer patients: a cross-sectional pilot study.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2021
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors at 2 institutions in 1 country.

Amy WallisPsychology Department, College of Health and Biomedicine, Victoria University, Melbourne, Australia. Amy.Wallis@vu.edu.au.ORCID 0000-0002-1019-3251
Michelle BallPsychology Department, College of Health and Biomedicine, Victoria University, Melbourne, Australia.
Henry ButtBioscreen (Aust) Pty Ltd., Melbourne, Australia.
Donald P LewisCFS Discovery Clinic, Donvale, Melbourne, Australia.
Sandra McKechnieCollege of Engineering and Science, Victoria University, Melbourne, Australia.
Phillip PaullBioscreen (Aust) Pty Ltd., Melbourne, Australia.
Amber Jaa-KweeCollege of Engineering and Science, Victoria University, Melbourne, Australia.
Dorothy BruckPsychology Department, College of Health and Biomedicine, Victoria University, Melbourne, Australia.
Victoria University · AUMelbourne Clinic · AU

Funding

EPA EP-C-15-010
6 · The paper itself

Abstract

backgroundPreliminary evidence suggests that the enteric microbiota may play a role in the expression of neurological symptoms in myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). Overlapping symptoms with the acute presentation of D-lactic acidosis has prompted the use of antibiotic treatment to target the overgrowth of species within the Streptococcus genus found in commensal enteric microbiota as a possible treatment for neurological symptoms in ME/CFS.

methodsAn open-label, repeated measures design was used to examine treatment efficacy and enable sex comparisons. Participants included 44 adult ME/CFS patients (27 females) from one specialist medical clinic with Streptococcus viable counts above 3.00 × 10

resultsLarge treatment effects were observed for the intention-to-treat sample with a reduction in Streptococcus viable count and improvement on several clinical outcomes including total symptoms, some sleep (less awakenings, greater efficiency and quality) and cognitive symptoms (attention, processing speed, cognitive flexibility, story memory and verbal fluency). Mood, fatigue and urine D:L lactate ratio remained similar across time. Ancillary results infer that shifts in microbiota were associated with more of the variance in clinical changes for males compared with females.

conclusionsResults support the notion that specific microorganisms interact with some ME/CFS symptoms and offer promise for the therapeutic potential of targeting gut dysbiosis in this population. Streptococcus spp. are not the primary or sole producers of D-lactate. Further investigation of lactate concentrations are needed to elucidate any role of D-lactate in this population. Concurrent microbial shifts that may be associated with clinical improvement (i.e., increased Bacteroides and Bifidobacterium or decreased Clostridium in males) invite enquiry into alternative strategies for individualised treatment. Trial Registration Australian and New Zealand Clinical Trial Registry (ACTRN12614001077651) 9th October 2014. https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=366933&isReview=true.

Indexed as

Gastrointestinal MicrobiomeNeuropsychological TestsSex CharacteristicsAdolescentAdultAgedColony Count, MicrobialDysbiosisFatigue Syndrome, ChronicFemaleHumansLactic AcidMaleMiddle AgedPilot ProjectsTreatment OutcomeLactic AcidAntibioticChronic fatigue syndromeClinical outcomesGut dysbiosisMicrobiota-gut-brainMyalgic encephalomyelitisNeuropsychological symptomsOpen-label pilotProbioticSex comparisonsStreptococcusTreatment

Identifiers

PMID29409505
PMCPMC5801817
OpenAlexW2785406142

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.