Multiple SclerosisPhase 2TRIOMSNCT01413243
Trichuris Suis Ova (TSO)in Recurrent Remittent Multiple Sclerosis and Clinically Isolated Syndrome
A Phase 2 study testing Trichuris suis ova in people with Multiple Sclerosis, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Trichuris suis ova
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2012to Jun 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- active Recurrent remittent Multiple Scleosis or Clinically isolated Syndrome
- inefficacy or intolerance for a therapy with Interferon-beta
- age 18 - 65
- EDSS <4
Who cannot join
- secondary or primary chronic progressive Multiple Sclerosis
- Immunomodulatoric or immunosuppressive therapy
Trial locations and contacts
1 site in 1 country.
Germany1 site
Charité - Universitätsmedizin Berlin, Department of Neurology
Berlin, State of Berlin, 10117
About this study
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
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.
Read the 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
- Conditions
- Multiple Sclerosis
- Being tested
- Trichuris suis ova
- Keywords
- Multipe sclerosis, Trichuris suis ova
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trichuris suis ovaDrug
Also called TSO
Trichuris suis ova 2500 eggs every 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| Drug: Trichuris suis ova | Experimental | Experimental: Trichuris suis ova (TSO) 2500 eggs every 2 weeks for 12 months Receives: Drug: Trichuris suis ova |
| Placebo | Placebo comparator | Drug: Placebo, fluid every 2 weeks Receives: Drug: Trichuris suis ova |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative number of new T2 hyperintensive in cerebral magnetic resonance imaging (MRI)
Measured: after 12 months of treatment
Secondary outcomes (5)
reduction NAA/Cr-ratio in MR-spectroscopy
Measured: after 12 month of treatment
Number of new Gadolinium lesions in magnetic resonance imaging (MRI) cerebral magnetic resonance imaging (MRI)
Measured: after 12 months of treatment
Volume of new T2 hyperintensive in cerebral magnetic resonance imaging (MRI)
Measured: after 12 months of treatment
Number of relapes, proression of diability measured in EDSS (Expanded Disability Status Scale) and MSFC (Multiple Sclerosis Functional Composite),
Measured: after 12 months of treatment
Number of Participants with Adverse Events
Measured: participants will be followed for the duration of the study and have every 3 month planed visits.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2011 (estimated)
- Study startSep 2012
- Primary completionDec 2016 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Berit Rosche, Charite University, Berlin, Germany
- Investigators
- Berit Rosche, M.D., Principal investigator, Charité-UniversityFriedemann Paul, M.D., Study chair, Charité - University, NeuroCure Clinical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01413243
- Sponsor's protocol ID
- TRIOMS-01
- Acronym
- TRIOMS
- Status last verified
- May 2016
- First submitted
- 8 Aug 2011
- Last updated
- 6 May 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Rosche B, Wernecke KD, Ohlraun S, Dorr JM, Paul F. Trichuris suis ova in relapsing-remitting multiple sclerosis and clinically isolated syndrome (TRIOMS): study protocol for a randomized controlled trial. Trials. 2013 Apr 25;14:112. doi: 10.1186/1745-6215-14-112.
PubMed 23782752
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01413243
- Acronym / sponsor ID
- TRIOMS / TRIOMS-01
- Conditions
- Multiple Sclerosis
- Keywords
- Multipe sclerosis, Trichuris suis ova
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 10 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug: Trichuris suis ova | Experimental | Drug: Trichuris suis ovaExperimental: Trichuris suis ova (TSO) 2500 eggs every 2 weeks for 12 months |
| Placebo | Placebo comparator | Drug: Trichuris suis ovaDrug: Placebo, fluid every 2 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- active Recurrent remittent Multiple Scleosis or Clinically isolated Syndrome
- inefficacy or intolerance for a therapy with Interferon-beta
- age 18 - 65
- EDSS <4
Key exclusion criteria (2 listed)
- secondary or primary chronic progressive Multiple Sclerosis
- Immunomodulatoric or immunosuppressive therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trichuris suis ovaAlso: TSOTrichuris suis ova 2500 eggs every 2 weeks | Drug | Drug: Trichuris suis ova, Placebo |
Primary outcome
Cumulative number of new T2 hyperintensive in cerebral magnetic resonance imaging (MRI)
Time frame: after 12 months of treatment
5 secondary outcomes
reduction NAA/Cr-ratio in MR-spectroscopy
Time frame: after 12 month of treatment
Number of new Gadolinium lesions in magnetic resonance imaging (MRI) cerebral magnetic resonance imaging (MRI)
Time frame: after 12 months of treatment
Volume of new T2 hyperintensive in cerebral magnetic resonance imaging (MRI)
Time frame: after 12 months of treatment
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
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.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2016.
- Derived from this study: PubMed 23782752Rosche B, Wernecke KD, Ohlraun S, Dorr JM, Paul F. Trichuris suis ova in relapsing-remitting multiple sclerosis and clinically isolated syndrome (TRIOMS): study protocol for a randomized controlled trial. Trials. 2013 Apr 25;14:112. doi: 10.1186/1745-6215-14-112.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Berit Rosche, M.D. principal investigator
Charité-University
Friedemann Paul, M.D. study chair
Charité - University, NeuroCure Clinical Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Trichuris suis ova in people with Multiple Sclerosis, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative number of new T2 hyperintensive in cerebral magnetic resonance imaging (MRI) (time frame: after 12 months of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01413243, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2016.