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

This study is currently recruiting participants.
Verified September 2012 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 14, 2012
Last verified: September 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Multiple Sclerosis
 Drug: Trichuris suis ova
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • Cumulative number of new T2 hyperintensive in cerebral magnetic resonance imaging (MRI) [ Time Frame: after 12 months of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 50
Study Start Date: September 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Drug: Trichuris suis ova
Experimental: Trichuris suis ova (TSO) 2500 eggs every 2 weeks for 12 months
 Drug: Trichuris suis ova
Trichuris suis ova 2500 eggs every 2 weeks
Other Name: TSO
Placebo Comparator: Placebo
Drug: Placebo, fluid every 2 weeks
 Drug: Trichuris suis ova
Trichuris suis ova 2500 eggs every 2 weeks
Other Name: TSO

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01413243

Contacts
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

Locations
Germany
Charité - Universitätsmedizin Berlin, Department of Neurology Recruiting
Berlin, Germany, 10117
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    
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
Principal Investigator: Berit Rosche, M.D. Charité-University
Study Chair: Friedemann Paul, M.D. Charité - University, NeuroCure Clinical Research Center
  More Information

No publications provided

Responsible Party: Berit Rosche, Dr. med., Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01413243     History of Changes
Other Study ID Numbers: TRIOMS-01
Study First Received: August 8, 2011
Last Updated: September 14, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Charite University, Berlin, Germany:
Multipe sclerosis, Trichuris suis ova

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
 Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013