Multiple SclerosisNCT03797937
Microbiome Benchmarking to Identify Perturbations in Multiple Sclerosis II
A study testing Magnetic resonance imaging (MRI) in people with Multiple Sclerosis, run by National MS Center Melsbroek at 2 sites in Belgium.
Trial summary
The goal of this longitudinal study is to (1) explore the association between the gut microbiota and inflammatory disease activity in early onset multiple sclerosis, (2) investigate whether/how gut microbial composition vary when patients experience a relapse, and (3) to assess whether the gut microbiota shows… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Magnetic resonance imaging (MRI)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 2 sitesBelgium
- Study dates
- 1 Nov 2018to 1 May 2022
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Diagnosis of MS (as defined by the 2010 McDonald criteria).
- Occurrence of symptoms no longer than 5 years before baseline.
- Aged 18-65.
- Willingness to participate in the study and to sign the informed consent.
- Willingness to participate to the study and to sign the informed consent.
- Aged >=18.
Who cannot join
- Treatment with high doses of systemic steroids 2 months before baseline.
- Use of antibiotics 3 months before baseline.
- Chronic gastrointestinal disease (e.g. inflammatory bowel disease, colon cancer).
- Other immune-mediated or autoimmune diseases (e.g. rheumatoid arthritis, diabetes type 1 and 2, psoriasis).
- Additional inclusion criteria for MS patients undergoing a relapse:
- Ability to provide a faecal sample within 4 weeks from onset of the first symptoms suggestive of a relapse, before cortisone treatment. A relapse is defined by a new clinical sign or clinical worsening of a previous sign/symptom persisting for >=24 hours in the absence of fever.
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- Additional exclusion criteria for MS patients undergoing a relapse:
- Treatment with cortisone before collection of baseline faecal sample.
- Evidence of a relapse less than 2 months before baseline.
- Switching disease modifying treatment less than 2 months before baseline.
- Neurodegenerative disorders.
- Chronic gastrointestinal disease (e.g. inflammatory bowel disease, colon cancer) or autoimmune diseases (e.g. rheumatoid arthritis, diabetes type 1, psoriasis).
- Use of antibiotics 3 months before baseline.
- Treatment with high doses of systemic steroids 2 months before baseline.
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites
Universitair Ziekenhuis Brussel
Jette, Brussels Capital, 1090
Nationaal Multiple Sclerose Centrum Melsbroek
Melsbroek, Vlaams-Brabant, 1820
About this study
The goal of this longitudinal study is to (1) explore the association between the gut microbiota and inflammatory disease activity in early onset multiple sclerosis, (2) investigate whether/how gut microbial composition vary when patients experience a relapse, and (3) to assess whether the gut microbiota shows increased similarities between affected pairs of first-degree relatives within the same family when compared with discordant pairs of first-degree relatives.
Read the detailed description
Using metagenomics, as well as clinical, immunological, and radiological observations, the investigators will investigate if active relapsing-remitting multiple sclerosis patients have a more pro-inflammatory gut microbiota signature than multiple sclerosis patients with less active disease and matched healthy controls.
More specifically, the investigators will investigate whether temporal variability of the gut microbiota is related to inflammatory disease activity in multiple sclerosis, whether changes in the gut microbiota are predictive of future inflammatory disease activity in multiple sclerosis, and whether gut microbiota characteristics are predictive of the disease course after 2 years.
- Conditions
- Multiple Sclerosis
- Being tested
- Magnetic resonance imaging (MRI)
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic resonance imaging (MRI)Other
MRI scanner
| Study group | Role | What they receive |
|---|---|---|
| Multiple sclerosis (MS) patients | Experimental | Patients will undergo magnetic resonance imaging (MRI). Stool and blood samples will be collected. Receives: Other: Magnetic resonance imaging (MRI) |
| Healthy controls | No intervention | Healthy controls will not undergo magnetic resonance imaging (MRI). Stool and blood samples will be collected. |
| Multiple sclerosis (MS) patients undergoing a relapse | No intervention | Multiple sclerosis (MS) patients undergoing a relapse will not undergo magnetic resonance imaging (MRI). Stool and blood samples will be collected. |
| Multiple sclerosis (MS) patients from multiplex MS families | No intervention | Multiple sclerosis (MS) patients from multiplex MS families will not undergo magnetic resonance imaging (MRI). Stool and blood samples will be collected. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical evidence for active disease
Time to first relapse (after baseline) will be reported for all patients.
Measured: 3 years
Secondary outcomes (1)
Radiological evidence for active disease
Occurrence of new contrast-enhancing T1 hyper intense lesions, or changes in white matter lesion volume (i.e. new or enlarging T2 hyper intense lesions)
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2019
- Study start1 Nov 2018
- Primary completion1 Nov 2021
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- National MS Center Melsbroek
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marie D'hooghe, National MS Center Melsbroek
- Investigators
- Marie D'hooghe, M.D., Principal investigator, National MS Center Melsbroek
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03797937
- Sponsor's protocol ID
- 2018BDM2
- Status last verified
- May 2022
- First submitted
- 5 Mar 2018
- Last updated
- 11 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microbiome Benchmarking to Identify Perturbations in Multiple Sclerosis II
- ClinicalTrials.gov ID
- NCT03797937
- Acronym / sponsor ID
- 2018BDM2
- Conditions
- Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- National MS Center MelsbroekUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 9 Jan 2019 (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 longitudinal study is to (1) explore the association between the gut microbiota and inflammatory disease activity in early onset multiple sclerosis, (2) investigate whether/how gut microbial composition vary when patients experience a relapse, and (3) to assess whether the gut microbiota shows increased similarities between affected pairs of first-degree relatives within the same family when compared with discordant pairs of first-degree relatives.
Detailed description
Using metagenomics, as well as clinical, immunological, and radiological observations, the investigators will investigate if active relapsing-remitting multiple sclerosis patients have a more pro-inflammatory gut microbiota signature than multiple sclerosis patients with less active disease and matched healthy controls.
More specifically, the investigators will investigate whether temporal variability of the gut microbiota is related to inflammatory disease activity in multiple sclerosis, whether changes in the gut microbiota are predictive of future inflammatory disease activity in multiple sclerosis, and whether gut microbiota characteristics are predictive of the disease course after 2 years.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Multiple sclerosis (MS) patients | Experimental | Other: Magnetic resonance imaging (MRI)Patients will undergo magnetic resonance imaging (MRI). Stool and blood samples will be collected. |
| Healthy controls | No intervention | –Healthy controls will not undergo magnetic resonance imaging (MRI). Stool and blood samples will be collected. |
| Multiple sclerosis (MS) patients undergoing a relapse | No intervention | –Multiple sclerosis (MS) patients undergoing a relapse will not undergo magnetic resonance imaging (MRI). Stool and blood samples will be collected. |
| Multiple sclerosis (MS) patients from multiplex MS families | No intervention | –Multiple sclerosis (MS) patients from multiplex MS families will not undergo magnetic resonance imaging (MRI). Stool and blood samples will be collected. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Diagnosis of MS (as defined by the 2010 McDonald criteria).
- Occurrence of symptoms no longer than 5 years before baseline.
- Aged 18-65.
- Willingness to participate in the study and to sign the informed consent.
- Willingness to participate to the study and to sign the informed consent.
Key exclusion criteria (14 listed)
- Treatment with high doses of systemic steroids 2 months before baseline.
- Use of antibiotics 3 months before baseline.
- Chronic gastrointestinal disease (e.g. inflammatory bowel disease, colon cancer).
- Other immune-mediated or autoimmune diseases (e.g. rheumatoid arthritis, diabetes type 1 and 2, psoriasis).
- Ability to provide a faecal sample within 4 weeks from onset of the first symptoms suggestive of a relapse, before cortisone treatment. A relapse is defined by a new clinical sign or clinical worsening of a previous sign/symptom persisting for >=24 hours in the absence of fever.
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 |
|---|---|---|
| Magnetic resonance imaging (MRI)MRI scanner | Other | Multiple sclerosis (MS) patients |
Primary outcome
Clinical evidence for active disease
Time frame: 3 years
Time to first relapse (after baseline) will be reported for all patients.
1 secondary outcome
Radiological evidence for active disease
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2022.
- Individual participant dataSharing planned: No
Related trials for Multiple Sclerosis
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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.
Marie D'hooghe, M.D. principal investigator
National MS Center Melsbroek
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic resonance imaging (MRI) in people with Multiple Sclerosis, run by National MS Center Melsbroek at 2 sites in Belgium.
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 6 inclusion and 14 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: finished, as of the sponsor's last update on 11 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Clinical evidence for active disease (time frame: 3 years). 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 11 May 2022.