Status:
TERMINATED
Trichuris Suis Ova (TSO)in Recurrent Remittent Multiple Sclerosis and Clinically Isolated Syndrome
Lead Sponsor:
Charite University, Berlin, Germany
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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 i...
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
- active Recurrent remittent Multiple Scleosis or Clinically isolated Syndrome
- inefficacy or intolerance for a therapy with Interferon-beta
- age 18 - 65
- EDSS \<4
Exclusion
- secondary or primary chronic progressive Multiple Sclerosis
- Immunomodulatoric or immunosuppressive therapy
Key Trial Info
Start Date :
September 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2017
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01413243
Start Date
September 1 2012
End Date
June 1 2017
Last Update
May 6 2016
Active Locations (1)
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1
Charité - Universitätsmedizin Berlin, Department of Neurology
Berlin, State of Berlin, Germany, 10117