Objectives: Dimethyl fumarate (DMF) therapy may cause a measureable change in bacterial
species of the gut. The primary objectives of this study are:
1. Determine whether a measureable change in bacterial species representation follows the
institution of DMF.
2. Determine whether a specific pattern of change in the microbiota phylotype with DMF
therapy correlates to onset and severity of gastrointestinal disturbances (heartburn,
nausea, flatulence, and diarrhea).
3. Determine whether any instability of microbiota phylotype representation persists
following the institution of DMF or whether stabilization relates to resolution of
gastrointestinal disturbances.
4. Determine whether there is a correlation between a pre-existing functional bowel
disorder and development or severity of gastrointestinal disturbances and of peripheral
eosinophilia.
Design: Double-blinded, prospective, single-center pilot study.
Patient Population: Individuals 18 years or older, with a confirmed diagnosis of a relapsing
form of multiple sclerosis.
Treatment Groups: This study will be an open-label prospective study design with respect to
MS immunomodulatory therapy choice. Study group will be defined as subjects with a relapsing
form of multiple sclerosis, as defined by the McDonald criteria, choosing to begin DMF
therapy.