The Gut Microbiome in Adult Multiple Sclerosis

NCT04929145 | Completed

• 1 other identifier: MICROMS5Y
• Study Type: observational
• Target: 152
• Locations: 1 country
• Sites: 2

Brief Summary

This study aims to assess the following research questions:

1. 1.Map and benchmark the gut microbiome of patients with RRMS, and PPMS versus matched healthy controls
2. 2.Determine whether RRMS or PPMS have a unique bias for a gut microbiome classification recently characterized.
3. 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. 4.Determine whether the gut microbiome is different in MS patients during a relapse.
5. 5.Determine whether the gut microbiome remains stable after 3 months

Conditions

Multiple Sclerosis

Keywords

gut microbiome

Outcome Measures

Primary Outcomes (1)

• 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.

  5 years

Secondary Outcomes (1)

• Clinical evidence for active disease

  5 years

Study Arms (1)

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).

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National MS Center Melsbroek: lead

Study Sites (2)

Universitair Ziekenhuis Brussel

Jette, Brussel-Hoofdstedelijk-Gewest, 1090, Belgium

Location

Nationaal Multiple Sclerose Centrum Melsbroek

Melsbroek, Vlaams-Brabant, 1820, Belgium

Location

Related Publications (1)

• 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.

  PMID: 36803643 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Fecal specimens from patients will be collected with standard kits and frozen for analysis. A blood sample of 10 ml will be drawn from a peripheral vein for the analysis of IL-1beta and Il-17 (proinflammatory cytokines) and and IL-10 (anti-inflammatory cytokine), and a range of amino acids (released by the gut) through HPLC. A serum sample will be deep frozen for further analyses. Some hair will be cut at the vertex posterior, close to the skull. A number of 5-10 hairs, corresponding to 5 mg, will be collected and stored in a cool place.

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Marie D'hooghe, M.D.

  National MS Center Melsbroek

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neurologist/Clinical Professor

Study Record Dates

• First Submitted: June 10, 2021
• First Posted: June 18, 2021
• Study Start: October 2, 2013
• Primary Completion: September 16, 2019
• Study Completion: April 1, 2020
• Last Updated: July 23, 2021

Record last verified: 2021-07

Locations

BE (2)