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

Multiple Sclerosis Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01413243
• Other study ID #: TRIOMS-01
• Status: Terminated
• Phase: Phase 2
• First received: August 8, 2011
• Last updated: May 5, 2016
• Start date: September 2012
• Est. completion date: June 2017

Study information

• Verified date: May 2016
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 50
• Est. completion date: June 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• Trichuris suis ova
Trichuris suis ova 2500 eggs every 2 weeks

Locations

Country	Name	City	State
Germany	Charité - Universitätsmedizin Berlin, Department of Neurology	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative number of new T2 hyperintensive in cerebral magnetic resonance imaging (MRI)		after 12 months of treatment	No
Secondary	reduction NAA/Cr-ratio in MR-spectroscopy		after 12 month of treatment	No
Secondary	Number of new Gadolinium lesions in magnetic resonance imaging (MRI) cerebral magnetic resonance imaging (MRI)		after 12 months of treatment	No
Secondary	Volume of new T2 hyperintensive in cerebral magnetic resonance imaging (MRI)		after 12 months of treatment	No
Secondary	Number of relapes, proression of diability measured in EDSS (Expanded Disability Status Scale) and MSFC (Multiple Sclerosis Functional Composite),		after 12 months of treatment	No
Secondary	Number of Participants with Adverse Events		participants will be followed for the duration of the study and have every 3 month planed visits.	Yes