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

This study is currently recruiting participants.
Verified September 2013 by Charite University, Berlin, Germany
Sponsor:
Information provided by (Responsible Party):
Berit Rosche, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01413243
First received: August 8, 2011
Last updated: September 16, 2013
Last verified: September 2013

August 8, 2011
September 16, 2013
September 2012
December 2016   (final data collection date for primary outcome measure)
Cumulative number of new T2 hyperintensive in cerebral magnetic resonance imaging (MRI) [ Time Frame: after 12 months of treatment ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01413243 on ClinicalTrials.gov Archive Site
  • reduction NAA/Cr-ratio in MR-spectroscopy [ Time Frame: after 12 month of treatment ] [ Designated as safety issue: No ]
  • Number of new Gadolinium lesions in magnetic resonance imaging (MRI) cerebral magnetic resonance imaging (MRI) [ Time Frame: after 12 months of treatment ] [ Designated as safety issue: No ]
  • Volume of new T2 hyperintensive in cerebral magnetic resonance imaging (MRI) [ Time Frame: after 12 months of treatment ] [ Designated as safety issue: No ]
  • Number of relapes, proression of diability measured in EDSS (Expanded Disability Status Scale) and MSFC (Multiple Sclerosis Functional Composite), [ Time Frame: after 12 months of treatment ] [ Designated as safety issue: No ]
  • Number of Participants with Adverse Events [ Time Frame: participants will be followed for the duration of the study and have every 3 month planed visits. ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Trichuris Suis Ova (TSO)in Recurrent Remittent Multiple Sclerosis and Clinically Isolated Syndrome
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

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

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Multiple Sclerosis
Drug: Trichuris suis ova
Trichuris suis ova 2500 eggs every 2 weeks
Other Name: TSO
  • Experimental: Drug: Trichuris suis ova
    Experimental: Trichuris suis ova (TSO) 2500 eggs every 2 weeks for 12 months
    Intervention: Drug: Trichuris suis ova
  • Placebo Comparator: Placebo
    Drug: Placebo, fluid every 2 weeks
    Intervention: Drug: Trichuris suis ova
Rosche B, Wernecke KD, Ohlraun S, Dörr 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
June 2017
December 2016   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact: Berit Rosche, M.D. +49 30 450 560 ext 343 berit.rosche@charite.de
Contact: Friedemann Paul, M.D. +49 30 450 639 ext 705 friedemann.paul@charite.de
Germany
 
NCT01413243
TRIOMS-01
No
Berit Rosche, Charite University, Berlin, Germany
Charite University, Berlin, Germany
Not Provided
Principal Investigator: Berit Rosche, M.D. Charité-University
Study Chair: Friedemann Paul, M.D. Charité - University, NeuroCure Clinical Research Center
Charite University, Berlin, Germany
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP