Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
25 participants
OBSERVATIONAL
2015-05-31
2020-12-31
Brief Summary
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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.
Detailed Description
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Gut microbiota will be characterized using a commercial service, Second Genome, utilizing bacterial DNA extraction from stool samples and 16S ribosomal RNA gene amplification, followed by high-throughput sequencing. Taxonomic profiling on the Illumina MiSeq system is cycled to generate paired 250-bp reads in Second Genome's protocols. These longer read lengths provide high-quality full length-reads of the gene to ensure the most accurate classification available through sequencing technologies. Next generation sequencing has emerged as a powerful tool for investigating microbial communities in large sample sets.
Serial stool samples will be collected from each subject, and sent to Second Genome for analysis. The first stool sample will be collected prior to the initial dose of DMF, with subsequent collections at defined time points over the course of the study. A more intensive analysis will focus on the first 12 weeks of treatment, a time during which development and resolution of gastrointestinal side effects typically take place on therapy. Treatment-emergent flushing severity will be recorded during this time using a 5-point Likert scale flushing severity survey. Gastrointestinal (G.I.) symptoms will be assessed using the Gastrointestinal Symptoms Rating Scale (GSRS) questionnaire, a validated, self-administered questionnaire that includes 15 questions, which assess severity of G.I. symptoms using a 7-point Likert scale in five domains: indigestion, diarrhea, constipation, abdominal pain and reflux. The severity of symptoms reported in the GSRS increases with increasing score. Other variables which potentially may alter the gastrointestinal microbiota and secondarily DMF tolerance will be assessed, including the identification of subjects predisposed to functional bowel disorders via use of the Rome III functional bowel survey, a validated clinical tool to identify at-risk individuals, diet composition, antibiotic exposure, steroid treatments for neurological relapses, use of prebiotic , probiotic, or vitamin D supplements, and H2 blocker or proton pump inhibitor (PPI) therapy, as gut pH changes impact the gut flora composition.Additional data on mood change over 24 weeks of DMF therapy, using the Hamilton Anxiety Measurement (HAM) Rating Scale and Patient Health Questionnaire-9 (PHQ-9) Depression Scale, will be collected and correlated to DMF-emergent G.I. disturbances, and to changes in bacterial and archaeal species in the gut flora.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Dimethyl fumarate
Observation of impact of dimethyl fumarate treatment initiation on mood and gut microbiome over the first 6 months of therapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age 18 years or older.
* Able to provide informed consent.
* Treatment naïve to DMF, Fumaderm or other fumarate containing compound.
* Neurologically stable within 4 weeks prior to screening.
* Stable gross diet composition type (Western, vegetarian with dairy, vegan, gluten-limited, Paleo) within 12 weeks of screening visit.
* Able to complete study specific questionnaires and demographic information via HIPAA compliant secure internet based portal.
* No oral antibiotics within 4 weeks of screening.
* Able to abide by safety surveillance monitoring and management as part of standard of care.
* Able and willing to comply with the protocol requirements for the duration of the study.
Exclusion Criteria
* G.I. diagnostic or therapeutic procedure within 24 weeks of screening visit, or at any time during participation in the study.
* Steroid therapy (oral or intravenous) within 4 weeks of screening visit.
* Chronic use of a proton pump inhibitor therapy (daily use for greater than 4 weeks) within 3 months of screening.
* Chronic use (i.e. daily use for greater than 4 weeks) of laxatives other than Colace within 6 months of screening.
* Intravenous antimicrobial therapy within 24 weeks of screening.
* Oral antimicrobial therapy within 4 weeks of screening.
* Dental procedure within 4 weeks of screening visit.
* Total parenteral nutrition (TPN) within 12 months of screening.
* History of Crohns disease, ulcerative colitis, biliary cirrhosis, celiac disease, chronic pancreatitis, gastric lap-band procedure, gastric or colon cancer, bowel resection, colitis within past 6 months.
* Women who are pregnant, breastfeeding, planning pregnancy, or potentially fertile and not willing to abide by effective contraception while being treated with DMF.
18 Years
ALL
No
Sponsors
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Biogen
INDUSTRY
Virginia Simnad
OTHER
Responsible Party
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Virginia Simnad
MD, M.Sc
Principal Investigators
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Virginia I Simnad, MD
Role: PRINCIPAL_INVESTIGATOR
EvergreenHealth
Locations
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EvergreenHealth MS Center
Kirkland, Washington, United States
Countries
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Central Contacts
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Facility Contacts
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Shalom E Kilcup
Role: primary
Other Identifiers
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VIS2014
Identifier Type: -
Identifier Source: org_study_id