MedTrace Logo

Impact of Tecfidera on Gut Microbiota

NCT02736279 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 25

Last updated 2016-11-04

No results posted yet for this study

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

Interventions

DRUG

Dimethyl fumarate

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

Sponsors & Collaborators

  • Biogen

    collaborator INDUSTRY

  • Virginia Simnad

    lead OTHER

Principal Investigators

  • Virginia I Simnad, MD · EvergreenHealth

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2020-06-30
Completion
2020-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02736279 on ClinicalTrials.gov