drugset / Trial / NCT01413243

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

NCT01413243 ↗

Phase 2 Terminated 50 enrolled Charite University, Berlin, Germany
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2012-09
Primary completion
2016-12
Completion
2017-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Trichuris suis ova Other / unclassified 2500 unknown Oral

Indications