Multiple SclerosisMICROMS5YNCT04929145
The Gut Microbiome in Adult Multiple Sclerosis
An observational study of Multiple Sclerosis, run by National MS Center Melsbroek at 2 sites in Belgium.
Trial summary
This study aims to assess the following research questions: 1. Map and benchmark the gut microbiome of patients with RRMS, and PPMS versus matched healthy controls 2. Determine whether RRMS or PPMS have a unique bias for a gut microbiome classification recently characterized. 3. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 152 participants
- Where
- 2 sitesBelgium
- Study dates
- 2 Oct 2013to Apr 2020
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: This is an exploratory study and there is no specific outcome on which a power calculation can be made. We included 122 patients with MS and 30 age and sex matched healthy controls as well.
Who may be able to join
- Signed written informed consent.
- RRMS or PPMS, as defined by the McDonald criteria.
- Ages 18-65 years.
- EDSS < 7
- Treatment with IFN-beta
Who cannot join
- SPMS without relapses during the past year at screening.
- Use of high dose systemic steroids within the last 2 months.
- Gastrointestinal disease, such as inflammatory bowel disease
- Use of antibiotics within the last 4 weeks.
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites
Universitair Ziekenhuis Brussel
Jette, Brussel-Hoofdstedelijk-Gewest, 1090
Nationaal Multiple Sclerose Centrum Melsbroek
Melsbroek, Vlaams-Brabant, 1820
About this study
Official title: Microbiome Benchmarking to Identify Perturbations in Multiple Sclerosis I
This study aims to assess the following research questions:
- Map and benchmark the gut microbiome of patients with RRMS, and PPMS versus matched healthy controls
- Determine whether RRMS or PPMS have a unique bias for a gut microbiome classification recently characterized.
- Search for relationship with inflammation, amino acid plasma levels, heart rate variability (vagus nerve tone) and hair cortisol as a biological marker of chronic stress
- Determine whether the gut microbiome is different in MS patients during a relapse.
- Determine whether the gut microbiome remains stable after 3 months
Read the detailed description
This study is a prospective multi-center cohort study (University Hospital Brussels, National Multiple Sclerosis Center Melsbroek). This is an exploratory study and there is no specific outcome on which a power calculation can be made. We will include different subgroups of patients with MS: stable non-benign RRMS, PPMS, benign MS [Benign MS is defined as RRMS with an EDSS ≤ 3, 15 years after disease onset], RRMS during a relapse (before the administration of corticosteroids) [Relapses are defined as the development of new or recurrent neurologic symptoms not associated with fever or infection or change in medication, lasting at least 24 hours, and accompanied by new, objective neurologic findings]. Age and sex matched healthy controls will be included as well. All participants will provide a faecal, hair, and blood sample twice (baseline and after 3 months). Patients will be assessed clinically at baseline, 3 months after baseline, and approximately 1, 2, 4.5 years after baseline.
The results of this study have the potential to identify novel simple strategies to strengthen or alter the microbiome ecosystem and strengthen the overall treatment process. In case of a positive result, this would form the basis for a follow-up study on medical modulation of the microbiome with the aim of finding new treatment options for MS.
- Conditions
- Multiple Sclerosis
- Keywords
- gut microbiome
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| MICROMS | No intervention will be administered. Stool, hair, and blood samples will be collected at baseline and three months post baseline. Clinical follow-up will occur at year 1, 2, and 4.5 (neurological consultation) and in-between visits (regular follow-up). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained disability worsening
Sustained disability worsening will be assessed using the Expanded Disability Status Scale (EDSS)-Plus outcome. This is a composite measure that assesses disability worsening based on changes of the EDSS score (difference of at least 1.5;1.0;0.5 depending on baseline score), the timed 25-foot walk (T25FW) score (>=20%), and the 9-hole peg test (9-HPT) score (>=20%). If worsening of any of these measures occurred, the patient has clinically deteriorated according to the EDSS-Plus outcome.
Measured: 5 years
Secondary outcomes (1)
Clinical evidence for active disease
Time to first relapse (after baseline) will be reported for all patients. Annualized relapse frequency
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study start2 Oct 2013
- Primary completion16 Sep 2019
- Study completionApr 2020
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.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 152 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
- NCT04929145
- Sponsor's protocol ID
- MICROMS5Y
- Acronym
- MICROMS5Y
- Status last verified
- Jul 2021
- First submitted
- 10 Jun 2021
- Last updated
- 23 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Devolder L, Pauwels A, Van Remoortel A, Falony G, Vieira-Silva S, Nagels G, De Keyser J, Raes J, D'Hooghe MB. Gut microbiome composition is associated with long-term disability worsening in multiple sclerosis. Gut Microbes. 2023 Jan-Dec;15(1):2180316. doi: 10.1080/19490976.2023.2180316.
PubMed 36803643
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microbiome Benchmarking to Identify Perturbations in Multiple Sclerosis I
- ClinicalTrials.gov ID
- NCT04929145
- Acronym / sponsor ID
- MICROMS5Y / MICROMS5Y
- Conditions
- Multiple Sclerosis
- Keywords
- gut microbiome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- National MS Center MelsbroekUniversity, hospital or other
- Study start
- 2 Oct 2013 (actual)
- Primary completion
- 16 Sep 2019 (actual)
- Study completion
- Apr 2020 (actual)
- First posted
- 18 Jun 2021 (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.
This study aims to assess the following research questions:
- Map and benchmark the gut microbiome of patients with RRMS, and PPMS versus matched healthy controls
- Determine whether RRMS or PPMS have a unique bias for a gut microbiome classification recently characterized.
- Search for relationship with inflammation, amino acid plasma levels, heart rate variability (vagus nerve tone) and hair cortisol as a biological marker of chronic stress
- Determine whether the gut microbiome is different in MS patients during a relapse.
- Determine whether the gut microbiome remains stable after 3 months
Detailed description
This study is a prospective multi-center cohort study (University Hospital Brussels, National Multiple Sclerosis Center Melsbroek). This is an exploratory study and there is no specific outcome on which a power calculation can be made. We will include different subgroups of patients with MS: stable non-benign RRMS, PPMS, benign MS [Benign MS is defined as RRMS with an EDSS ≤ 3, 15 years after disease onset], RRMS during a relapse (before the administration of corticosteroids) [Relapses are defined as the development of new or recurrent neurologic symptoms not associated with fever or infection or change in medication, lasting at least 24 hours, and accompanied by new, objective neurologic findings]. Age and sex matched healthy controls will be included as well. All participants will provide a faecal, hair, and blood sample twice (baseline and after 3 months). Patients will be assessed clinically at baseline, 3 months after baseline, and approximately 1, 2, 4.5 years after baseline.
The results of this study have the potential to identify novel simple strategies to strengthen or alter the microbiome ecosystem and strengthen the overall treatment process. In case of a positive result, this would form the basis for a follow-up study on medical modulation of the microbiome with the aim of finding new treatment options for MS.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MICROMS | – | –No intervention will be administered. Stool, hair, and blood samples will be collected at baseline and three months post baseline. Clinical follow-up will occur at year 1, 2, and 4.5 (neurological consultation) and in-between visits (regular follow-up). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This is an exploratory study and there is no specific outcome on which a power calculation can be made. We included 122 patients with MS and 30 age and sex matched healthy controls as well.
Key inclusion criteria (5 listed)
- Signed written informed consent.
- RRMS or PPMS, as defined by the McDonald criteria.
- Ages 18-65 years.
- EDSS < 7
- Treatment with IFN-beta
Key exclusion criteria (4 listed)
- SPMS without relapses during the past year at screening.
- Use of high dose systemic steroids within the last 2 months.
- Gastrointestinal disease, such as inflammatory bowel disease
- Use of antibiotics within the last 4 weeks.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sustained disability worsening
Time frame: 5 years
Sustained disability worsening will be assessed using the Expanded Disability Status Scale (EDSS)-Plus outcome. This is a composite measure that assesses disability worsening based on changes of the EDSS score (difference of at least 1.5;1.0;0.5 depending on baseline score), the timed 25-foot walk (T25FW) score (>=20%), and the 9-hole peg test (9-HPT) score (>=20%). If worsening of any of these measures occurred, the patient has clinically deteriorated according to the EDSS-Plus outcome.
1 secondary outcome
Clinical evidence for active disease
Time frame: 5 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 23 Jul 2021.
- Derived from this study: PubMed 36803643Devolder L, Pauwels A, Van Remoortel A, Falony G, Vieira-Silva S, Nagels G, De Keyser J, Raes J, D'Hooghe MB. Gut microbiome composition is associated with long-term disability worsening in multiple sclerosis. Gut Microbes. 2023 Jan-Dec;15(1):2180316. doi: 10.1080/19490976.2023.2180316.
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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?
An observational study of 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 5 inclusion and 4 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 23 Jul 2021. 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?
Sustained disability worsening (time frame: 5 years). 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 NCT04929145, 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 23 Jul 2021.