Trichuris Suis Ova (TSO)in Recurrent Remittent Multiple Sclerosis and Clinically Isolated Syndrome

Study Overview
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Brief Summary
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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
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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

Official Title
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Trichuris Suis Ova (TSO)in Recurrent Remittent Multiple Sclerosis and Clinically Isolated Syndrome - A Monocentric, Prospective, Randomized, Double-blind and Placebo-controlled Phase 2 Trial

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Drug: Trichuris suis ova


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Drug: Trichuris suis ova<br>Experimental: Trichuris suis ova (TSO) 2500 eggs every 2 weeks for 12 months | Drug: Trichuris suis ova<br>* Trichuris suis ova 2500 eggs every 2 weeks<br>* Other names: TSO;|
| Placebo Comparator: Placebo<br>Drug: Placebo, fluid every 2 weeks | Drug: Trichuris suis ova<br>* Trichuris suis ova 2500 eggs every 2 weeks<br>* Other names: TSO;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative number of new T2 hyperintensive in cerebral magnetic resonance imaging (MRI) |  | after 12 months of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multipe sclerosis, Trichuris suis ova