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

Primary Purpose

Multiple Sclerosis

Status
Terminated
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Trichuris suis ova
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Multipe sclerosis, Trichuris suis ova

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Charité - Universitätsmedizin Berlin, Department of Neurology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Drug: Trichuris suis ova

Placebo

Arm Description

Experimental: Trichuris suis ova (TSO) 2500 eggs every 2 weeks for 12 months

Drug: Placebo, fluid every 2 weeks

Outcomes

Primary Outcome Measures

Cumulative number of new T2 hyperintensive in cerebral magnetic resonance imaging (MRI)

Secondary Outcome Measures

reduction NAA/Cr-ratio in MR-spectroscopy
Number of new Gadolinium lesions in magnetic resonance imaging (MRI) cerebral magnetic resonance imaging (MRI)
Volume of new T2 hyperintensive in cerebral magnetic resonance imaging (MRI)
Number of relapes, proression of diability measured in EDSS (Expanded Disability Status Scale) and MSFC (Multiple Sclerosis Functional Composite),
Number of Participants with Adverse Events

Full Information

First Posted
August 8, 2011
Last Updated
May 5, 2016
Sponsor
Charite University, Berlin, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT01413243
Brief Title
Trichuris Suis Ova (TSO)in Recurrent Remittent Multiple Sclerosis and Clinically Isolated Syndrome
Acronym
TRIOMS
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Terminated
Study Start Date
September 2012 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
June 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Multipe sclerosis, Trichuris suis ova

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Drug: Trichuris suis ova
Arm Type
Experimental
Arm Description
Experimental: Trichuris suis ova (TSO) 2500 eggs every 2 weeks for 12 months
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Drug: Placebo, fluid every 2 weeks
Intervention Type
Drug
Intervention Name(s)
Trichuris suis ova
Other Intervention Name(s)
TSO
Intervention Description
Trichuris suis ova 2500 eggs every 2 weeks
Primary Outcome Measure Information:
Title
Cumulative number of new T2 hyperintensive in cerebral magnetic resonance imaging (MRI)
Time Frame
after 12 months of treatment
Secondary Outcome Measure Information:
Title
reduction NAA/Cr-ratio in MR-spectroscopy
Time Frame
after 12 month of treatment
Title
Number of new Gadolinium lesions in magnetic resonance imaging (MRI) cerebral magnetic resonance imaging (MRI)
Time Frame
after 12 months of treatment
Title
Volume of new T2 hyperintensive in cerebral magnetic resonance imaging (MRI)
Time Frame
after 12 months of treatment
Title
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
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Berit Rosche, M.D.
Organizational Affiliation
Charité-University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Friedemann Paul, M.D.
Organizational Affiliation
Charité - University, NeuroCure Clinical Research Center
Official's Role
Study Chair
Facility Information:
Facility Name
Charité - Universitätsmedizin Berlin, Department of Neurology
City
Berlin
ZIP/Postal Code
10117
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
23782752
Citation
Rosche B, Wernecke KD, Ohlraun S, Dorr 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.
Results Reference
derived

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

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