Multiple Sclerosis
Conditions
Keywords
Multipe sclerosis, Trichuris suis ova
Brief summary
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.
Detailed description
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
Interventions
Trichuris suis ova 2500 eggs every 2 weeks
Sponsors
Charite University, Berlin, Germany
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* active Recurrent remittent Multiple Scleosis or Clinically isolated Syndrome * inefficacy or intolerance for a therapy with Interferon-beta * age 18 - 65 * EDSS \<4
Exclusion criteria
* secondary or primary chronic progressive Multiple Sclerosis * Immunomodulatoric or immunosuppressive therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cumulative number of new T2 hyperintensive in cerebral magnetic resonance imaging (MRI) | after 12 months of treatment |
Secondary
| Measure | Time frame |
|---|---|
| reduction NAA/Cr-ratio in MR-spectroscopy | after 12 month of treatment |
| Number of new Gadolinium lesions in magnetic resonance imaging (MRI) cerebral magnetic resonance imaging (MRI) | after 12 months of treatment |
| Volume of new T2 hyperintensive in cerebral magnetic resonance imaging (MRI) | after 12 months of treatment |
| Number of relapes, proression of diability measured in EDSS (Expanded Disability Status Scale) and MSFC (Multiple Sclerosis Functional Composite), | after 12 months of treatment |
| Number of Participants with Adverse Events | participants will be followed for the duration of the study and have every 3 month planed visits. |
Countries
Germany
Outcome results
None listed