Microbiome Benchmarking to Identify Perturbations in Multiple Sclerosis II

NCT03797937 | Completed

• 1 other identifier: 2018BDM2
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 2

Brief 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 increased similarities between affected pairs of first-degree relatives within the same family when compared with discordant pairs of first-degree relatives.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• Clinical evidence for active disease

  Time to first relapse (after baseline) will be reported for all patients.

  3 years

Secondary Outcomes (1)

• Radiological evidence for active disease

  3 years

Study Arms (4)

Multiple sclerosis (MS) patients

EXPERIMENTAL

Patients will undergo magnetic resonance imaging (MRI). Stool and blood samples will be collected.

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.

Interventions

Magnetic resonance imaging (MRI) OTHER

MRI scanner

Multiple sclerosis (MS) patients

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.
• Willingness to participate to the study and to sign the informed consent.
• Aged \>=18.
• 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.

Sponsors & Collaborators

• National MS Center Melsbroek: lead

Study Sites (2)

Universitair Ziekenhuis Brussel

Jette, Brussels Capital, 1090, Belgium

Location

Nationaal Multiple Sclerose Centrum Melsbroek

Melsbroek, Vlaams-Brabant, 1820, Belgium

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Marie D'hooghe, M.D.

  National MS Center Melsbroek

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: March 5, 2018
• First Posted: January 9, 2019
• Study Start: November 1, 2018
• Primary Completion: November 1, 2021
• Study Completion: May 1, 2022
• Last Updated: May 11, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

BE (2)