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

Phase 2

Terminated

• Conditions: Multiple Sclerosis
• Interventions: Drug: Trichuris suis ova

• Registration Number: NCT01413243
• Lead Sponsor: Charite University, Berlin, Germany

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

Study Timeline

• Study First Submitted: 2011-08-08
• Study First Submitted QC: 2011-08-09
• Study First Posted: 2011-08-10
• Study Start: 2012-09
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-05
• Last Update Posted: 2016-05-06
• Primary Completion: 2016-12
• Study Completion: 2017-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 50

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Drug: Trichuris suis ova	Trichuris suis ova	Experimental: Trichuris suis ova (TSO) 2500 eggs every 2 weeks for 12 months
Placebo	Trichuris suis ova	Drug: Placebo, fluid every 2 weeks

Primary Outcome Measures

Name	Time	Method
Cumulative number of new T2 hyperintensive in cerebral magnetic resonance imaging (MRI)	after 12 months of treatment

Secondary Outcome Measures

Name	Time	Method
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
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
Number of Participants with Adverse Events	participants will be followed for the duration of the study and have every 3 month planed visits.

Trial Locations

Locations (1)

Charité - Universitätsmedizin Berlin, Department of Neurology; 🇩🇪 Berlin, Germany