Impact of Tecfidera on Gut Microbiota

NCT02736279 | Unknown

• 1 other identifier: VIS2014
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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. 1.Determine whether a measureable change in bacterial species representation follows the institution of DMF.
2. 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. 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. 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.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• Measure change in the diversity and relative abundance of bacterial and archaeal species in the gut microbiota following the start of DMF therapy.

  16S ribosomal RNA gene sequencing for taxanomic classification of both known and unknown bacteria. This method quantifies the relative abundance of bacterial and archaeal species at each time point of sampling, and changes in the composition of species at specified time points from baseline (weeks 0, 4, 8, 12, and 24 following DMF treatment initiation.

  Weeks 0 (baseline), 4,8,12,and 24

Secondary Outcomes (3)

• Measure change in anxiety level within the first 6 months following the start of dimethyl fumarate therapy.

  Weeks 0 (baseline), 12, and 24

• Measure change in depression level within the first 6 months following the start of dimethyl fumarate therapy.

  Weeks 0 (baseline), 12, and 24

• Define pre-existing functional bowel disturbance as a predictor of GI symptoms development and severity following the start of dimethyl fumarate treatment.

  Weeks 0 (baseline); 1-12 and 24

Interventions

Dimethyl fumarate DRUG

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

Also known as: Tecfidera

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects will be recruited from a single center located in Seattle, Washington. Eligibility will be determined following a clinical decision to begin dimethyl fumarate therapy for a relapsing form of multiple sclerosis. Study population will reflect the local community composition, which is predominantly Caucasian.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Virginia Simnad: lead
• Biogen: collaborator

Study Sites (1)

EvergreenHealth MS Center

Kirkland, Washington, 98034, United States

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Dimethyl Fumarate

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Fumarates; Dicarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Virginia I Simnad, MD

  EvergreenHealth

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shalom E Kilcup

CONTACT

425-899-5369; SEKilcup@evergreenhealth.com

Carey L Gonzales

CONTACT

425-899-5374; CLGonzales@evergreenhealth.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, M.Sc

Study Record Dates

• First Submitted: March 22, 2016
• First Posted: April 13, 2016
• Study Start: May 1, 2015
• Primary Completion: June 1, 2020
• Study Completion: December 1, 2020
• Last Updated: November 4, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will share

Locations

US (1)