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

Charité University Medicine Berlin

Status and phase: Terminated; Phase 2

Conditions: Multiple Sclerosis

Treatments: Drug: Trichuris suis ova

Study type: Interventional

Funder types: Other

Identifiers

NCT01413243

TRIOMS-01

Details and patient eligibility

About

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.

Full 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

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups, including a placebo group

Drug: Trichuris suis ova

Experimental group

Description:

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

Treatment:

Drug: Trichuris suis ova

Placebo

Placebo Comparator group

Description:

Drug: Placebo, fluid every 2 weeks

Treatment:

Drug: Trichuris suis ova