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

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01413243
First Posted: August 10, 2011
Last Update Posted: May 6, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Berit Rosche, Charite University, Berlin, Germany
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 Berit Rosche, 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 ]

Secondary Outcome Measures:
  • reduction NAA/Cr-ratio in MR-spectroscopy [ Time Frame: after 12 month of treatment ]
  • Number of new Gadolinium lesions in magnetic resonance imaging (MRI) cerebral magnetic resonance imaging (MRI) [ Time Frame: after 12 months of treatment ]
  • Volume of new T2 hyperintensive in cerebral magnetic resonance imaging (MRI) [ Time Frame: after 12 months of treatment ]
  • 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 ]
  • 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. ]
Estimated Enrollment: 50
Study Start Date: September 2012
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: December 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01413243


Locations
Germany
Charité - Universitätsmedizin Berlin, Department of Neurology
Berlin, Germany, 10117
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Berit Rosche, Dr. med., Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01413243     History of Changes
Other Study ID Numbers: TRIOMS-01
First Submitted: August 8, 2011
First Posted: August 10, 2011
Last Update Posted: May 6, 2016
Last Verified: May 2016

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

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