Clinical trial NCT04929145: The Gut Microbiome in Adult Multiple Sclerosis
Official title: Microbiome Benchmarking to Identify Perturbations in Multiple Sclerosis I
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Keywords: gut microbiome
Lead sponsor: National MS Center Melsbroek
Sponsor class: OTHER
First posted: 2021-06-18
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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. 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
4. Determine whether the gut microbiome is different in MS patients during a relapse.
5. 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.

Eligibility criteria: Inclusion Criteria:

1. Signed written informed consent.
2. RRMS or PPMS, as defined by the McDonald criteria.
3. Ages 18-65 years.
4. EDSS \< 7
5. Treatment with IFN-beta

Exclusion Criteria:

1. SPMS without relapses during the past year at screening.
2. Use of high dose systemic steroids within the last 2 months.
3. Gastrointestinal disease, such as inflammatory bowel disease
4. Use of antibiotics within the last 4 weeks.

Primary outcomes:
measure: Sustained disability worsening
timeFrame: 5 years
Secondary outcomes:
measure: Clinical evidence for active disease
timeFrame: 5 years
Other outcomes:
Locations:
city: Jette
country: Belgium
facility: Universitair Ziekenhuis Brussel
state: Brussel-Hoofdstedelijk-Gewest
city: Melsbroek
country: Belgium
facility: Nationaal Multiple Sclerose Centrum Melsbroek
state: Vlaams-Brabant
Study officials:
affiliation: National MS Center Melsbroek
name: Marie D'hooghe, M.D.
role: PRINCIPAL_INVESTIGATOR
References: