Multiple Sclerosis, Relapsing-RemittingCLAProMSNCT05920018
Effects of a Combined Supplementation of Conjugated Linoleic Acid (CLA) and Probiotics (Vivomixx®) as add-on to a First-line Immunotherapy in Relapsing-remitting Multiple Sclerosis
A study testing Vivomixx® and Conjugated linoleic acid (CLA/Tonalin® FFA 80) in people with Multiple Sclerosis, Relapsing-Remitting, run by Universität Münster at 4 sites in Germany.
Trial summary
The goal of this randomized, double-blind, placebo-controlled multicenter study is to investigate whether the combination of food supplementation with Tonalin® and specific probiotics is a safe and effective add-on to first-line disease modifying treatment (DMT, interferon-beta derivatives as well as glatirameracetate… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Multiple Sclerosis, Relapsing-Remitting
- What is being tested?
- Vivomixx® and Conjugated linoleic acid (CLA/Tonalin® FFA 80)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 4 sitesGermany
- Study dates
- 2 Oct 2023to Feb 2025
- Phase
- Interventional
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Relapsing-remitting multiple sclerosis according to current McDonald Criteria, EDSS maximal 5.5, 18-60 years
- stable treatment with first-line DMT (IFNbeta, teriflunomide or glatiramer acetate/ other glatirameroids) for at least 6 months
- absence of a clinical relapse for at least 3 months before inclusion
- Written informed consent
Who cannot join
- diagnosis of primary or secondary progressive MS or other active autoimmune disease
- intake/administration of the following disease modifying therapies:
- at any time point: alemtuzumab, cladribine
- during the last 6 months before inclusion: natalizumab, fingolimod, dimethyl fumarate, siponimod
- during the last 12 months before inclusion: mitoxantron, ocrelizumab, ofatumumab, rituximab
- ingestion of other dietary supplementation (e.g. vitamins, probiotics, iron, calcium, prebiotics, such as omega-3-fatty acids)
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- significant gastroenterological abnormality (e.g. inflammatory bowel disease, short bowel disease, preexisting digestive lesions)
- accompanying systemic immunosuppressive treatment
- relevant dietary restriction (e.g. strictly vegan nutrition)
- women during pregnancy or lactation
Trial locations and contacts
4 sites in 1 country.
Germany4 sites, 4 recruiting
- Recruiting
Universitätsklinik Heidelberg, Neurologische Klinik
Heidelberg, Baden-Wurttemberg, 69120
Brigitte Wildemann, Prof.
- Recruiting
Neurological study centre, Department of Neurology
Mainz, Hesse
- Recruiting
IIT unit of the Department of Neurology with Institute of Translational Neurology
Münster, North Rhine-Westphalia
Luisa Klotz, Prof., +4925183 ext. 48165, luisa.klotz@ukmuenster.de
- Recruiting
Klinikum Osnabrück GmbH, Klinik für Neurologie
Osnabrück, North Rhine-Westphalia, 49076
Susanne Windhagen, Dr.
About this study
Official title: Effects of a Combined Supplementation of Conjugated Linoleic Acid (CLA/Tonalin® FFA 80) and Probiotics (Vivomixx®/VSL#3) as add-on to a First-line Immunotherapy in Relapsing-remitting Multiple Sclerosis
The goal of this randomized, double-blind, placebo-controlled multicenter study is to investigate whether the combination of food supplementation with Tonalin® and specific probiotics is a safe and effective add-on to first-line disease modifying treatment (DMT, interferon-beta derivatives as well as glatirameracetate and other glatirameroids) in relapsing remitting MS (RRMS).
100 patients will be randomly assigned in a 1:1 ratio to receive either both food supplements for 48 weeks or to receive placebo in addition to their established first-line disease modifying treatment (DMT). The two randomized groups will be compared concerning the change in volume of T2-weighted hyperintense lesions from baseline to 48 weeks.
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Being tested
- Vivomixx®, Conjugated linoleic acid (CLA/Tonalin® FFA 80), Maltose placebo, Sunflower oil placebo
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vivomixx®Dietary supplement
Daily application of four sachets, i.e. 1.800 bio bacteria/day for 48 weeks
Conjugated linoleic acid (CLA/Tonalin® FFA 80)Dietary supplement
Daily application of two capsules p.o., i.e. 2g/day for 48 weeks
Maltose placeboOther
Daily application of four sachets for 48 weeks
Sunflower oil placeboOther
Daily application of two capsules p.o for 48 weeks
| Study group | Role | What they receive |
|---|---|---|
| Dietary supplement | Active comparator | 1. Vivomixx®/VSL#3 sachets p.o. (1.800 bio bacteria/d) and
2. Conjugated linoleic acid (CLA/Tonalin® FFA 80) capsules p.o. (2 g/d) Receives: Dietary Supplement: Vivomixx®; Dietary Supplement: Conjugated linoleic acid (CLA/Tonalin® FFA 80) |
| Placebo-control | Placebo comparator | 1. Maltose as Placebo to Vivomixx® and
2. Sunflower oil as Placebo to Conjugated linoleic acid (CLA/Tonalin® FFA 80) Receives: Other: Maltose placebo; Other: Sunflower oil placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of volume of 'hyperintense lesions in the T2-weighted MRI images' between baseline and after 48 weeks of therapy
The two randomised study groups (intervention and placebo groups) are compared with regard to the change of volume of new or enlarged 'hyperintense lesions in the T2-weighted MRI images' (hereafter T2 lesions) between the start of the study and after 48 weeks.
T2 lesions were chosen as primary endpoint as this has been used as a surrogate marker of efficacy in several recent MS studies
Measured: 48 weeks
Secondary outcomes (4)
Change in T2 lesions at 48 weeks compared to baseline
Change in T2 lesions at 48 weeks compared to baseline (yes/no)
Measured: 48 weeks
Number of new or enlarging T2-weighted hyperintense lesions
Number of new or enlarging T2-weighted hyperintense lesions based on the comparison of brain MRI-scans after 48 weeks of intervention as compared to baseline
Measured: 48 weeks
Volume of new or enlarged 'hyperintense lesions in the T2-weighted MRI images' as well as double inversion recovery (DIR) images
Volume of new or enlarged 'hyperintense lesions in the T2-weighted MRI images' as well as double inversion recovery (DIR) images will be compared between the intervention arm and the placebo arm. This approach has been recently published and rises the probability to detect new brain lesions in MS without application of gadolinium with a sensitivity of 98.1%
Measured: 48 weeks
Annualized relapse rate
All relapses confirmed by a physician will be documented and analysed. Clinical relapses are defined as onset of new or recurrent neurological symptoms lasting at least 24 hours, accompanied by objective abnormalities on a neurological examination, which are not explained solely by non-MS processes such as fever, infection, severe stress or drug toxicity. Annualized relapse rates are compared between the two study groups.
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2023
- Study start2 Oct 2023
- Primary completionFeb 2025 (estimated)
- Study completionFeb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Sclerosis, Relapsing-RemittingStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- two-arm, randomized, double-blind, placebo-controlled, multicenter
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universität Münster
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luisa Klotz, Prof., Principal investigator, Universität Münster
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05920018
- Sponsor's protocol ID
- WWU21_0013
- Acronym
- CLAProMS
- Status last verified
- May 2024
- First submitted
- 2 May 2023
- Last updated
- 8 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Combined Supplementation of Conjugated Linoleic Acid (CLA/Tonalin® FFA 80) and Probiotics (Vivomixx®/VSL#3) as add-on to a First-line Immunotherapy in Relapsing-remitting Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT05920018
- Acronym / sponsor ID
- CLAProMS / WWU21_0013
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Universität MünsterUniversity, hospital or other
- Study start
- 2 Oct 2023 (actual)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 27 Jun 2023 (actual)
- 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.
The goal of this randomized, double-blind, placebo-controlled multicenter study is to investigate whether the combination of food supplementation with Tonalin® and specific probiotics is a safe and effective add-on to first-line disease modifying treatment (DMT, interferon-beta derivatives as well as glatirameracetate and other glatirameroids) in relapsing remitting MS (RRMS).
100 patients will be randomly assigned in a 1:1 ratio to receive either both food supplements for 48 weeks or to receive placebo in addition to their established first-line disease modifying treatment (DMT). The two randomized groups will be compared concerning the change in volume of T2-weighted hyperintense lesions from baseline to 48 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- two-arm, randomized, double-blind, placebo-controlled, multicenter
| Arm | Type | Receives |
|---|---|---|
| Dietary supplement | Active comparator | Dietary Supplement: Vivomixx®, Dietary Supplement: Conjugated linoleic acid (CLA/Tonalin® FFA 80)1. Vivomixx®/VSL#3 sachets p.o. (1.800 bio bacteria/d) and 2. Conjugated linoleic acid (CLA/Tonalin® FFA 80) capsules p.o. (2 g/d) |
| Placebo-control | Placebo comparator | Other: Maltose placebo, Other: Sunflower oil placebo1. Maltose as Placebo to Vivomixx® and 2. Sunflower oil as Placebo to Conjugated linoleic acid (CLA/Tonalin® FFA 80) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Relapsing-remitting multiple sclerosis according to current McDonald Criteria, EDSS maximal 5.5, 18-60 years
- stable treatment with first-line DMT (IFNbeta, teriflunomide or glatiramer acetate/ other glatirameroids) for at least 6 months
- absence of a clinical relapse for at least 3 months before inclusion
- Written informed consent
Key exclusion criteria (10 listed)
- diagnosis of primary or secondary progressive MS or other active autoimmune disease
- intake/administration of the following disease modifying therapies:
- ingestion of other dietary supplementation (e.g. vitamins, probiotics, iron, calcium, prebiotics, such as omega-3-fatty acids)
- significant gastroenterological abnormality (e.g. inflammatory bowel disease, short bowel disease, preexisting digestive lesions)
- accompanying systemic immunosuppressive treatment
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 |
|---|---|---|
| Vivomixx®Daily application of four sachets, i.e. 1.800 bio bacteria/day for 48 weeks | Dietary supplement | Dietary supplement |
| Conjugated linoleic acid (CLA/Tonalin® FFA 80)Daily application of two capsules p.o., i.e. 2g/day for 48 weeks | Dietary supplement | Dietary supplement |
| Maltose placeboDaily application of four sachets for 48 weeks | Other | Placebo-control |
| Sunflower oil placeboDaily application of two capsules p.o for 48 weeks | Other | Placebo-control |
Primary outcome
Change of volume of 'hyperintense lesions in the T2-weighted MRI images' between baseline and after 48 weeks of therapy
Time frame: 48 weeks
The two randomised study groups (intervention and placebo groups) are compared with regard to the change of volume of new or enlarged 'hyperintense lesions in the T2-weighted MRI images' (hereafter T2 lesions) between the start of the study and after 48 weeks. T2 lesions were chosen as primary endpoint as this has been used as a surrogate marker of efficacy in several recent MS studies
4 secondary outcomes
Change in T2 lesions at 48 weeks compared to baseline
Time frame: 48 weeks
Number of new or enlarging T2-weighted hyperintense lesions
Time frame: 48 weeks
Volume of new or enlarged 'hyperintense lesions in the T2-weighted MRI images' as well as double inversion recovery (DIR) images
Time frame: 48 weeks
Annualized relapse rate
Time frame: 48 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
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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.
Luisa Klotz, Prof. principal investigator
Universität Münster
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vivomixx® and Conjugated linoleic acid (CLA/Tonalin® FFA 80) in people with Multiple Sclerosis, Relapsing-Remitting, run by Universität Münster at 4 sites 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 10 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: status not confirmed, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Luisa Klotz, Prof. (+49 (0)251 83 ext. 48165, MS-Studienambulanz@ukmuenster.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of volume of 'hyperintense lesions in the T2-weighted MRI images' between baseline and after 48 weeks of therapy (time frame: 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 May 2024.