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

• Published in: Multiple sclerosis Vol. 17; no. 6; pp. 743 - 754
• Main Authors: Fleming, JO, Isaak, A, Lee, JE, Luzzio, CC, Carrithers, MD, Cook, TD, Field, AS, Boland, J, Fabry, Z
• Format: Journal Article
• Language: English
• Published: London, England SAGE Publications 01.06.2011; Sage Publications Ltd
• Subjects: Administration, Oral; Adult; Animals; Antibodies, Helminth - blood; Autoimmune diseases; Biomarkers - blood; Brain - pathology; C-Reactive Protein - metabolism; Female; Humans; Hygiene; Immunomodulation; Inflammatory bowel diseases; Interleukin 10; Interleukin 4; Interleukin-10 - blood; Interleukin-4 - blood; Magnetic Resonance Imaging; Male; Multiple sclerosis; Multiple Sclerosis, Relapsing-Remitting - diagnosis; Multiple Sclerosis, Relapsing-Remitting - immunology; Multiple Sclerosis, Relapsing-Remitting - therapy; Ova; Pilot Projects; probiotics; Probiotics - adverse effects; Serum levels; Side effects; Time Factors; Treatment Outcome; Trichuris - immunology; Up-Regulation; Wisconsin; Young Adult; Wisconsin; immunomodulation; probiotic; hygiene hypothesis; multiple sclerosis; whipworm; cytokines; Trichuris
• ISSN: 1352-4585; 1477-0970; 1477-0970
• DOI: 10.1177/1352458511398054

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.