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

May 5, 2016 updated by: Berit Rosche, Charite University, Berlin, Germany

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • TSO
Placebo Comparator: Placebo
Drug: Placebo, fluid every 2 weeks
Drug: Trichuris suis ova
Trichuris suis ova 2500 eggs every 2 weeks
Other Names:
  • TSO

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cumulative number of new T2 hyperintensive in cerebral magnetic resonance imaging (MRI)
Time Frame: after 12 months of treatment
after 12 months of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
reduction NAA/Cr-ratio in MR-spectroscopy
Time Frame: after 12 month of treatment
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
after 12 months of treatment
Volume of new T2 hyperintensive in cerebral magnetic resonance imaging (MRI)
Time Frame: after 12 months of treatment
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
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.
participants will be followed for the duration of the study and have every 3 month planed visits.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

June 1, 2017

Study Registration Dates

First Submitted

August 8, 2011

First Submitted That Met QC Criteria

August 9, 2011

First Posted (Estimate)

August 10, 2011

Study Record Updates

Last Update Posted (Estimate)

May 6, 2016

Last Update Submitted That Met QC Criteria

May 5, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TRIOMS-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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