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.

This study included 49 patients with clinical multiple sclerosis (MS), 105 patients with other neurological diseases (OND), and 30 controls. It compared seven assays for CNS IgG synthesis with the oligoclonal banding (agarose electrophoresis) method. A newly developed assay which determined the differences between the measured and calculated CSF/serum IgG ratio (M-C value), using albumin as a reference protein, was particularly sensitive to the diagnosis of MS. In 40/46 (87%) of patients with MS, the M-C value was 0.001 or more, while oligoclonal banding was found in CSF of 38/49 (78%). In the 30 controls, the M-C value was invariably less than 0.001 and oligoclonal banding was not found. In patients with OND, 26/104 (25%) had an M-C value of 0.001 of greater while 11/105 (11%) had oligoclonal banding in CSF. The M-C value also offers a convenient means of quantifying CNS IgG synthesis during disease activity of treatment. It is concluded that the combined use of the oligoclonal banding method and the M-C value determination gives the greatest predictive value for the diagnosis of MS.