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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drug: Trichuris suis ova | Experimental | Experimental: Trichuris suis ova (TSO) 2500 eggs every 2 weeks for 12 months |
|
| Placebo | Placebo Comparator | Drug: Placebo, fluid every 2 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trichuris suis ova | Drug | Trichuris suis ova 2500 eggs every 2 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative number of new T2 hyperintensive in cerebral magnetic resonance imaging (MRI) | after 12 months of treatment |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Berit Rosche, M.D. | Charité-University | Principal Investigator |
| Friedemann Paul, M.D. | Charité - University, NeuroCure Clinical Research Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charité - Universitätsmedizin Berlin, Department of Neurology | Berlin | State of Berlin | 10117 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23782752 | Derived | Rosche B, Wernecke KD, Ohlraun S, Dorr JM, Paul F. Trichuris suis ova in relapsing-remitting multiple sclerosis and clinically isolated syndrome (TRIOMS): study protocol for a randomized controlled trial. Trials. 2013 Apr 25;14:112. doi: 10.1186/1745-6215-14-112. |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| 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. |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |