Trichuris Suis Ova (TSO)in Recurrent Remittent Multiple Sclerosis and Clinically Isolated Syndrome (TRIOMS)
This study has been terminated.
Sponsor:
Charite University, Berlin, Germany
Information provided by (Responsible Party):
Berit Rosche, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01413243
First received: August 8, 2011
Last updated: May 5, 2016
Last verified: May 2016
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Sclerosis |
Drug: Trichuris suis ova |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Charite University, Berlin, Germany:
Primary Outcome Measures:
- Cumulative number of new T2 hyperintensive in cerebral magnetic resonance imaging (MRI) [ Time Frame: after 12 months of treatment ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- reduction NAA/Cr-ratio in MR-spectroscopy [ Time Frame: after 12 month of treatment ] [ Designated as safety issue: No ]
- Number of new Gadolinium lesions in magnetic resonance imaging (MRI) cerebral magnetic resonance imaging (MRI) [ Time Frame: after 12 months of treatment ] [ Designated as safety issue: No ]
- Volume of new T2 hyperintensive in cerebral magnetic resonance imaging (MRI) [ Time Frame: after 12 months of treatment ] [ Designated as safety issue: No ]
- Number of relapes, proression of diability measured in EDSS (Expanded Disability Status Scale) and MSFC (Multiple Sclerosis Functional Composite), [ Time Frame: after 12 months of treatment ] [ Designated as safety issue: No ]
- Number of Participants with Adverse Events [ Time Frame: participants will be followed for the duration of the study and have every 3 month planed visits. ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 50 |
| Study Start Date: | September 2012 |
| Estimated Study Completion Date: | June 2017 |
| Estimated Primary Completion Date: | December 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Drug: Trichuris suis ova
Experimental: Trichuris suis ova (TSO) 2500 eggs every 2 weeks for 12 months
|
Drug: Trichuris suis ova
Trichuris suis ova 2500 eggs every 2 weeks
Other Name: TSO
|
|
Placebo Comparator: Placebo
Drug: Placebo, fluid every 2 weeks
|
Drug: Trichuris suis ova
Trichuris suis ova 2500 eggs every 2 weeks
Other Name: TSO
|
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
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01413243
Please refer to this study by its ClinicalTrials.gov identifier: NCT01413243
Locations
| Germany | |
| Charité - Universitätsmedizin Berlin, Department of Neurology | |
| Berlin, Germany, 10117 | |
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
| Principal Investigator: | Berit Rosche, M.D. | Charité-University |
| Study Chair: | Friedemann Paul, M.D. | Charité - University, NeuroCure Clinical Research Center |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Berit Rosche, Dr. med., Charite University, Berlin, Germany |
| ClinicalTrials.gov Identifier: | NCT01413243 History of Changes |
| Other Study ID Numbers: | TRIOMS-01 |
| Study First Received: | August 8, 2011 |
| Last Updated: | May 5, 2016 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by Charite University, Berlin, Germany:
|
Multipe sclerosis, Trichuris suis ova |
Additional relevant MeSH terms:
|
Sclerosis Multiple Sclerosis Pathologic Processes Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System |
Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases |
ClinicalTrials.gov processed this record on September 30, 2016