Document Detail


Probiotic helminth administration in relapsing-remitting multiple sclerosis: a phase 1 study.
MedLine Citation:
PMID:  21372112     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: Probiotic 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.
OBJECTIVE: To 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.
METHODS: Five 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.
RESULTS: The 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.
CONCLUSION: TSO 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.
Authors:
J O Fleming; A Isaak; J E Lee; C C Luzzio; M D Carrithers; T D Cook; A S Field; J Boland; Z Fabry
Publication Detail:
Type:  Clinical Trial, Phase I; Journal Article; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't     Date:  2011-03-03
Journal Detail:
Title:  Multiple sclerosis (Houndmills, Basingstoke, England)     Volume:  17     ISSN:  1477-0970     ISO Abbreviation:  Mult. Scler.     Publication Date:  2011 Jun 
Date Detail:
Created Date:  2011-06-20     Completed Date:  2011-10-14     Revised Date:  2014-02-03    
Medline Journal Info:
Nlm Unique ID:  9509185     Medline TA:  Mult Scler     Country:  England    
Other Details:
Languages:  eng     Pagination:  743-54     Citation Subset:  IM    
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00645749
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MeSH Terms
Descriptor/Qualifier:
Administration, Oral
Adult
Animals
Antibodies, Helminth / blood
Biological Markers / blood
Brain / pathology
C-Reactive Protein / metabolism
Female
Humans
Interleukin-10 / blood
Interleukin-4 / blood
Magnetic Resonance Imaging
Male
Multiple Sclerosis, Relapsing-Remitting / diagnosis,  immunology,  therapy*
Pilot Projects
Probiotics* / adverse effects
Time Factors
Treatment Outcome
Trichuris* / immunology
Up-Regulation
Wisconsin
Young Adult
Grant Support
ID/Acronym/Agency:
1R56AI091462-01/AI/NIAID NIH HHS; R56 AI091462/AI/NIAID NIH HHS
Chemical
Reg. No./Substance:
0/Antibodies, Helminth; 0/Biological Markers; 0/IL10 protein, human; 0/IL4 protein, human; 130068-27-8/Interleukin-10; 207137-56-2/Interleukin-4; 9007-41-4/C-Reactive Protein
Comments/Corrections

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