Microbiome Benchmarking to Identify Perturbations in Multiple Sclerosi
Microbiome Benchmarking to Identify Perturbations in Multiple Sclerosis II
What it found
We found no results in the registry or in papers.
This trial finished 5 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- Magnetic resonance imaging (MRI)
What it measured
Main measures
Clinical evidence for active disease
3 years
Relapses
Other measures (1)
Radiological evidence for active disease
3 years
MRI lesions
Who could take part
MS (type not specified) · 18 to 55
Show the full criteria
Inclusion 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.
Exclusion criteria
Not separately supplied in the registry.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
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History
Started
Nov 2018
Main results due
Nov 2021
Finished
May 2022