Clinical trial NCT01413243: Trichuris Suis Ova (TSO)in Recurrent Remittent Multiple Sclerosis and Clinically Isolated Syndrome
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Multiple Sclerosis
Keywords: Multipe sclerosis, Trichuris suis ova
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2011-08-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Cumulative number of new T2 hyperintensive in cerebral magnetic resonance imaging (MRI)
timeFrame: after 12 months of treatment
Secondary outcomes:
measure: reduction NAA/Cr-ratio in MR-spectroscopy
timeFrame: after 12 month of treatment
measure: Number of new Gadolinium lesions in magnetic resonance imaging (MRI) cerebral magnetic resonance imaging (MRI)
timeFrame: after 12 months of treatment
measure: Volume of new T2 hyperintensive in cerebral magnetic resonance imaging (MRI)
timeFrame: after 12 months of treatment
measure: Number of relapes, proression of diability measured in EDSS (Expanded Disability Status Scale) and MSFC (Multiple Sclerosis Functional Composite),
timeFrame: after 12 months of treatment
measure: Number of Participants with Adverse Events
timeFrame: participants will be followed for the duration of the study and have every 3 month planed visits.
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin, Department of Neurology
Study officials:
affiliation: Charité-University
name: Berit Rosche, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Charité - University, NeuroCure Clinical Research Center
name: Friedemann Paul, M.D.
role: STUDY_CHAIR
References:
citation: 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.