Back to results

Microbiome Benchmarking to Identify Perturbations in Multiple Sclerosis II

Primary Purpose

Multiple Sclerosis

Status

Completed

Phase

Not Applicable

Locations

Belgium

Study Type

Interventional

Intervention

Magnetic resonance imaging (MRI)

About this trial

This is an interventional prevention trial for Multiple Sclerosis

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria patients:

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.

Exclusion Criteria patients:

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.

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.

Inclusion criteria healthy controls:

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

Exclusion criteria healthy controls:

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.

Sites / Locations

Universitair Ziekenhuis Brussel
Nationaal Multiple Sclerose Centrum Melsbroek

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

No Intervention

Arm Label

Multiple sclerosis (MS) patients

Healthy controls

Multiple sclerosis (MS) patients undergoing a relapse

Multiple sclerosis (MS) patients from multiplex MS families

Arm Description

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

Healthy controls will not undergo magnetic resonance imaging (MRI). Stool and blood samples will be collected.

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 will not undergo magnetic resonance imaging (MRI). Stool and blood samples will be collected.

Outcomes

Primary Outcome Measures

Clinical evidence for active disease

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

Secondary Outcome Measures

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)

Full Information

NCT ID

NCT03797937

First Posted

March 5, 2018

Last Updated

May 10, 2022

Sponsor

National MS Center Melsbroek

1. Study Identification

Unique Protocol Identification Number

NCT03797937

Brief Title

Microbiome Benchmarking to Identify Perturbations in Multiple Sclerosis II

Official Title

Microbiome Benchmarking to Identify Perturbations in Multiple Sclerosis II

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Completed

Study Start Date

November 1, 2018 (Actual)

Primary Completion Date

November 1, 2021 (Actual)

Study Completion Date

May 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

National MS Center Melsbroek

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Sclerosis

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

250 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Multiple sclerosis (MS) patients

Arm Type

Experimental

Arm Description

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

Arm Title

Healthy controls

Arm Type

No Intervention

Arm Description

Healthy controls will not undergo magnetic resonance imaging (MRI). Stool and blood samples will be collected.

Arm Title

Multiple sclerosis (MS) patients undergoing a relapse

Arm Type

No Intervention

Arm Description

Multiple sclerosis (MS) patients undergoing a relapse will not undergo magnetic resonance imaging (MRI). Stool and blood samples will be collected.

Arm Title

Multiple sclerosis (MS) patients from multiplex MS families

Arm Type

No Intervention

Arm Description

Multiple sclerosis (MS) patients from multiplex MS families will not undergo magnetic resonance imaging (MRI). Stool and blood samples will be collected.

Intervention Type

Other

Intervention Name(s)

Magnetic resonance imaging (MRI)

Intervention Description

MRI scanner

Primary Outcome Measure Information:

Title

Clinical evidence for active disease

Description

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

Time Frame

3 years

Secondary Outcome Measure Information:

Title

Radiological evidence for active disease

Description

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)

Time Frame

3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria patients: 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. Exclusion Criteria patients: 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. 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. Inclusion criteria healthy controls: Willingness to participate to the study and to sign the informed consent. Aged >=18. Exclusion criteria healthy controls: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Marie D'hooghe, M.D.

Organizational Affiliation

National MS Center Melsbroek

Official's Role

Principal Investigator

Facility Information:

Facility Name

Universitair Ziekenhuis Brussel

City

Jette

State/Province

Brussel

ZIP/Postal Code

1090

Country

Belgium

Facility Name

Nationaal Multiple Sclerose Centrum Melsbroek

City

Melsbroek

State/Province

Vlaams-Brabant

ZIP/Postal Code

1820

Country

Belgium

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Microbiome Benchmarking to Identify Perturbations in Multiple Sclerosis II

We'll reach out to this number within 24 hrs