NCT01413243

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2 multiple-sclerosis

Timeline
Completed

Started Sep 2012

Longer than P75 for phase_2 multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 8, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 10, 2011

Completed
1.1 years until next milestone

Study Start

First participant enrolled

September 1, 2012

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

May 6, 2016

Status Verified

May 1, 2016

Enrollment Period

4.3 years

First QC Date

August 8, 2011

Last Update Submit

May 5, 2016

Conditions

Multiple Sclerosis

Keywords

Multipe sclerosis, Trichuris suis ova

Outcome Measures

Primary Outcomes (1)

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

    after 12 months of treatment

Secondary Outcomes (5)

  • reduction NAA/Cr-ratio in MR-spectroscopy

    after 12 month of treatment

  • Number of new Gadolinium lesions in magnetic resonance imaging (MRI) cerebral magnetic resonance imaging (MRI)

    after 12 months of treatment

  • Volume of new T2 hyperintensive in cerebral magnetic resonance imaging (MRI)

    after 12 months of treatment

  • Number of relapes, proression of diability measured in EDSS (Expanded Disability Status Scale) and MSFC (Multiple Sclerosis Functional Composite),

    after 12 months of treatment

  • Number of Participants with Adverse Events

    participants will be followed for the duration of the study and have every 3 month planed visits.

Study Arms (2)

Drug: Trichuris suis ova

EXPERIMENTAL

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

Drug: Trichuris suis ova

Placebo

PLACEBO COMPARATOR

Drug: Placebo, fluid every 2 weeks

Drug: Trichuris suis ova

Interventions

Trichuris suis ovaDRUG

Trichuris suis ova 2500 eggs every 2 weeks

Also known as: TSO
Drug: Trichuris suis ovaPlacebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • active Recurrent remittent Multiple Scleosis or Clinically isolated Syndrome
  • inefficacy or intolerance for a therapy with Interferon-beta
  • age 18 - 65
  • EDSS \<4

You may not qualify if:

  • secondary or primary chronic progressive Multiple Sclerosis
  • Immunomodulatoric or immunosuppressive therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charité - Universitätsmedizin Berlin, Department of Neurology

Berlin, State of Berlin, 10117, Germany

Location

Related Publications (1)

  • 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.

    PMID: 23782752DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Berit Rosche, M.D.

    Charité-University

    PRINCIPAL INVESTIGATOR

  • Friedemann Paul, M.D.

    Charité - University, NeuroCure Clinical Research Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. med.

Study Record Dates

First Submitted

August 8, 2011

First Posted

August 10, 2011

Study Start

September 1, 2012

Primary Completion

December 1, 2016

Study Completion

June 1, 2017

Last Updated

May 6, 2016

Record last verified: 2016-05

Locations

DE(1)