Trichuris Suis Ova (TSO)in Recurrent Remittent Multiple Sclerosis and
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
What it found
The trial ended early for another reason (see below).
What was tested
Treatment tested
- Trichuris suis ova
What it measured
Main measures
Cumulative number of new T2 hyperintensive in cerebral magnetic resonance imaging (MRI)
after 12 months of treatment
MRI lesions
Other measures (5)
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
MRI lesionsVolume of new T2 hyperintensive in cerebral magnetic resonance imaging (MRI)
after 12 months of treatment
MRI lesionsNumber of relapes, proression of diability measured in EDSS (Expanded Disability Status Scale) and MSFC (Multiple Sclerosis Functional Composite),
after 12 months of treatment
Disability progressionNumber of Participants with Adverse Events
participants will be followed for the duration of the study and have every 3 month planed visits.
Safety
Who could take part
Early (CIS/RIS) · 18 to 65
Show the full 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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
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History
Started
Sept 2012
Main results due
Dec 2016
Finished
Jun 2017