Recruiting

Tecfidera

Sponsor:

Virginia Simnad

Code:

NCT02736279

Conditions

Multiple Sclerosis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Dimethyl fumarate

Study Details

Brief summary:

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.

Conditions

Multiple Sclerosis

Study ID

NCT02736279

Start date

May, 2015

Status verified date

Nov, 2016

Completion date

Dec, 2020

Anticipated

Primary completion date

Jun, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Confirmed diagnosis of a relapsing form of multiple sclerosis by McDonald 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:

  • Treatment with immunosuppressive therapies (other than steroids) within 12 months of screening, experimental or FDA approved cell trafficking modulators, experimental immune cell vaccines, or stem cell therapy.
  • 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.

Study Design

Enrollment

25 participants

Anticipated

Interventions and Outcome Measures

Interventions

Dimethyl fumarate

Observation of impact of dimethyl fumarate treatment initiation on mood and gut microbiome over the first 6 months of therapy

Primary outcome measure

  • Measure change in the diversity and relative abundance of bacterial and archaeal species in the gut microbiota following the start of DMF therapy. [ Time Frame: Weeks 0 (baseline), 4,8,12,and 24 ]

Central Contacts and Locations

Central contacts

Shalom E Kilcup

425-899-5369SEKilcup@evergreenhealth.com

Carey L Gonzales

425-899-5374CLGonzales@evergreenhealth.com

Locations

EvergreenHealth MS Center

Recruiting

Kirkland, Washington, United States, 98034

Contacts

Shalom E Kilcup

425-899-5369SEKilcup@evergreenhealth.com

Principal Investigator:

Virginia I Simnad, MD, M.Sc

More Information

Sponsor

Virginia Simnad

Last update posted

Nov 4, 2016

Last verified

Nov, 2016

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Virginia Simnad on 2016-11-04.