Trichuris suis ova (TSO) is a probiotic treatment based on the hygiene hypothesis, that has proven safe and effective in autoimmune inflammatory bowel disease. Clinical trails indicate that helminth infections have an immunomodulatory effect in multiple sclerosis as well. Investigators hypothesize that TSO® 2500 eggs given oral every 2 weeks for 12 months is - due to its immunomodulatory and antiinflammatory effect - in recurrent remittent multiple sclerosis and clinically isolated syndrome significantly more effective than an oral placebo treatment as assed by new T2 lesions in cerebral magnetic resonance imaging and clinical examination.
TSO has an impact on the Th1-Th2 balance and effects Il-10 producing B-cells, mechanisms that result in an antiinflammatory effect. A 12 month treatmet with TSO is safe and well-tolerated
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
50
Trichuris suis ova 2500 eggs every 2 weeks
Charité - Universitätsmedizin Berlin, Department of Neurology
Berlin, State of Berlin, Germany
Cumulative number of new T2 hyperintensive in cerebral magnetic resonance imaging (MRI)
Time frame: after 12 months of treatment
reduction NAA/Cr-ratio in MR-spectroscopy
Time frame: after 12 month of treatment
Number of new Gadolinium lesions in magnetic resonance imaging (MRI) cerebral magnetic resonance imaging (MRI)
Time frame: after 12 months of treatment
Volume of new T2 hyperintensive in cerebral magnetic resonance imaging (MRI)
Time frame: after 12 months of treatment
Number of relapes, proression of diability measured in EDSS (Expanded Disability Status Scale) and MSFC (Multiple Sclerosis Functional Composite),
Time frame: after 12 months of treatment
Number of Participants with Adverse Events
Time frame: participants will be followed for the duration of the study and have every 3 month planed visits.
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