Safety and efficacy of helminth treatment in relapsing-remitting multiple sclerosis: Results of the HINT 2 clinical trial

Author:

Fleming John1,Hernandez Gianna2,Hartman Leslie3,Maksimovic Jane3,Nace Sara3,Lawler Benjamin4,Risa Todd5,Cook Thomas6,Agni Rashmi2,Reichelderfer Mark7,Luzzio Christopher1,Rolak Loren4,Field Aaron3,Fabry Zsuzsanna2

Affiliation:

1. Department of Neurology, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA

2. Department of Pathology and Laboratory Medicine, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA

3. Department of Radiology, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA

4. Department of Neurology, Marshfield Clinic Health System, Marshfield WI, USA

5. Department of Radiology, Marshfield Clinic Health System, Marshfield WI, USA

6. Department of Biostatistics and Medical Informatics, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA

7. Department of Internal Medicine, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA

Abstract

Background: The hygiene hypothesis suggests that microbial replacement may be therapeutic in allergic and autoimmune diseases. Nevertheless, the results of helminth treatment, including in multiple sclerosis (MS), have been inconclusive. Objective: To assess safety and brain magnetic resonance imaging (MRI) activity in subjects with relapsing-remitting multiple sclerosis (RRMS) during oral administration of ova from the porcine whipworm, Trichuris suis (TSO). Methods: A total of 16 disease-modifying treatment (DMT) naive RRMS subjects were studied in a baseline versus treatment (BVT) controlled prospective study. MRI scans were performed during 5 months of screening-observation, 10 months of treatment, and 4 months of post-treatment surveillance. Results: No serious symptoms or adverse events occurred during treatment. For the cohort, there was a trend consistent with a 35% diminution in active lesions when observation MRIs were compared to treatment MRIs ( p = 0.08), and at the level of individuals, 12 of 16 subjects improved during TSO treatment. T regulatory lymphocytes were increased during TSO treatment. Conclusion: TSO is safe in RRMS subjects. Potentially favorable MRI outcomes and immunoregulatory changes were observed during TSO treatment; however, the magnitude of these effects was modest, and there was considerable variation among the responses of individual subjects.

Funder

National Institutes of Health

National Multiple Sclerosis Society

Publisher

SAGE Publications

Subject

Clinical Neurology,Neurology

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