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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2017-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Trichuris Suis Ova Therapy for Relapsing Multiple Sclerosis - a Safety Study

NCT01006941

Relapsing Multiple Sclerosis

COMPLETED PHASE2

Effect of Probiotics on Relapsing-Remitting Multiple Sclerosis

NCT07346924

Multiple Sclerosis (MS) Relapsing Remitting

COMPLETED NA

Oral FMT (Fecal Microbial Transplant) in Subjects with Multiple Sclerosis

NCT04096443

Multiple Sclerosis

ACTIVE_NOT_RECRUITING EARLY_PHASE1

A Trial of Bile Acid Supplementation in Patients With Multiple Sclerosis

NCT03423121

Progressive Multiple Sclerosis

COMPLETED PHASE1/PHASE2

Efficacy of Anti-Tubercular Vaccination in Multiple Sclerosis

NCT00202410

Multiple Sclerosis

COMPLETED PHASE2/PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Multiple Sclerosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Drug: Trichuris suis ova

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

Group Type EXPERIMENTAL

Trichuris suis ova

Intervention Type DRUG

Trichuris suis ova 2500 eggs every 2 weeks

Placebo

Drug: Placebo, fluid every 2 weeks

Group Type PLACEBO_COMPARATOR

Trichuris suis ova

Intervention Type DRUG

Trichuris suis ova 2500 eggs every 2 weeks

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.