Evidence map›Paper›PMID 21372112›Full record

ArticleMultiple sclerosis (Houndmills, Basingstoke, England)2011

Probiotic helminth administration in relapsing-remitting multiple sclerosis: a phase 1 study.

J O Fleming, A Isaak, J E Lee, C C Luzzio, M D Carrithers, T D Cook, A S Field, J Boland, Z Fabry

Registry-linked trialAbstract readClinical Trial, Phase I
In one paragraph

Article in Multiple sclerosis (Houndmills, Basingstoke, England), 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01734941 (A Phase 2 Randomized Three-Arm Double-Blind Placebo-Controlled Study to Evaluate the Safety and Efficacy of 16 Weeks of Treatment With Trichuris Suis Ova), which is not on this map. Cited by 115 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
115citing papers in PubMed, 2 pooled it
14.6field-weighted citation impact, top 1% 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.

NCT01734941 phase2terminatednot on this mapstarted 2014, after this paper: background citation

A Phase 2 Randomized Three-Arm Double-Blind Placebo-Controlled Study to Evaluate the Safety and Efficacy of 16 Weeks of Treatment With Trichuris Suis Ova (TSO) Therapy in Pediatric Patients Ages 6 to 17 With Autism

TypeinterventionalSponsorHadassah Medical OrganizationRan2014 to 2015Enrolled9ConditionsAutistic Spectrum DisordersArmsTSO, Placebo
3 · Its place in the literature

Who cites it

115 citing papers in PubMed, 2 syntheses or guidelines pooled it, 256 citations in OpenAlex.

  1. Pooled it
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  8. Homo sapiens, industrialisation and the environmental mismatch hypothesis.Biological reviews of the Cambridge Philosophical Society · 2026
    Review
  9. Review
  10. Frontiers in immunology · 2026
    Review
  11. Review
  12. Isolation ofF1000Research · 2026
    Article
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  14. Thinking outside the brain: Gut microbiome influence on innate immunity within neurodegenerative disease.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2024
    Review
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  16. Article
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55 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 2 institutions in 1 country.

J O FlemingDepartment of Neurology, University of Wisconsin School of Medicine and Public Health, Madison, WI 53792, USA. fleming@neurology.wisc.edu
A Isaak
J E Lee
C C Luzzio
M D Carrithers
T D Cook
A S Field
J Boland
Z Fabry
University of Wisconsin–Madison · USUniversity of California, San Francisco · US

Funding

Immunomodulation of Relapsing Remitting Multiple Sclerosis by Gut ParasitesR56AI091462 · NIAID · UNIVERSITY OF WISCONSIN-MADISON · PI FABRY, ZSUZSANNA · 2010 to 2010
$371k
NIAID NIH HHS 1R56AI091462-01NIAID NIH HHS R56 AI091462
6 · The paper itself

Abstract

backgroundProbiotic treatment strategy based on the hygiene hypothesis, such as administration of ova from the non-pathogenic helminth, Trichuris suis, (TSO) has proven safe and effective in autoimmune inflammatory bowel disease.

objectiveTo study the safety and effects of TSO in a second autoimmune disease, multiple sclerosis (MS), we conducted the phase 1 Helminth-induced Immunomodulatory Therapy (HINT 1) study.

methodsFive subjects with newly diagnosed, treatment-naive relapsing-remitting multiple sclerosis (RRMS) were given 2500 TSO orally every 2 weeks for 3 months in a baseline versus treatment control exploratory trial.

resultsThe mean number of new gadolinium-enhancing magnetic resonance imaging (MRI) lesions (n-Gd+) fell from 6.6 at baseline to 2.0 at the end of TSO administration, and 2 months after TSO was discontinued, the mean number of n-Gd+ rose to 5.8. No significant adverse effects were observed. In preliminary immunological investigations, increases in the serum level of the cytokines IL-4 and IL-10 were noted in four of the five subjects.

conclusionTSO was well tolerated in the first human study of this novel probiotic in RRMS, and favorable trends were observed in exploratory MRI and immunological assessments. Further investigations will be required to fully explore the safety, effects, and mechanism of action of this immunomodulatory treatment.

Indexed as

ProbioticsTrichurisAdministration, OralAdultAnimalsAntibodies, HelminthBiomarkersBrainC-Reactive ProteinFemaleHumansInterleukin-10Interleukin-4Magnetic Resonance ImagingMaleMultiple Sclerosis, Relapsing-RemittingAntibodies, HelminthBiomarkersC-Reactive ProteinIL10 protein, humanIL4 protein, humanInterleukin-10Interleukin-4

Identifiers

PMID21372112
PMCPMC3894910
OpenAlexW1979413298

What OpenQuestion holds

Textmetadata
LicenceTDM
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.