Accepted for/Published in: JMIR Research Protocols
Date Submitted: Sep 6, 2019
Date Accepted: Jun 3, 2020
Alterations of Gut Microbiota and the Brain-Immune-Intestine Axis in Patients with Relapsing Remitting Multiple Sclerosis after Treatment with Oral Cladribine: Protocol for a Prospective Observational Study.
ABSTRACT
Background:
Immunological factors are the key to the pathogenesis of multiple sclerosis (MS). Conjointly, environmental factors are known to affect MS disease onset and progression. The intestinal microbiota in MS patients differs from controls and between patients with and without relapses. The microbiota plays an important role in shaping the immune system. Recent studies have shown evidence of the presence of an association between the gut microbiota and inflammatory pathways in the central nervous system. However, the function of this brain-immune-intestine axis and its possible value for predicting treatment effect in MS patients is currently unknown.
Objective:
Our goal is to examine if (changes in) gut and oral microbiota and simultaneous changes in the immune response are a predictor for the treatment response in subjects with active relapsing remitting MS (RRMS) on oral cladribine.
Methods:
This is a prospective, observational, multi-centre study. Eligible subjects are patients with RRMS between the age of 18 and 55 years who will start treatment with oral cladribine. Patients who used probiotics one month prior to start of oral cladribine are excluded. At baseline (before start), after 3, 12 and 24 months the Expanded Disability Status Scale (EDSS) will be assessed and a fecal, oral and blood sample will be collected. Also, subjects will be asked to register their food intake for 7 consecutive days following the visits. After 24 months a Magnetic Resonance Imaging (MRI) of the brain is performed. Responders are subjects without relapses, without progression on EDSS and without radiological progression on MRI.
Results:
Inclusion started from January 2019. Nine patients are included at the moment. The aim is to include 80 patients in 10 participating centres during a period of approximately 24 months. Final results are expected in 2023.
Conclusions:
The results of the BIA study contribute to precision medicine in patients with RRMS and better understanding of the brain-immune-intestine axis.
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