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Tecfidera and the Gut Microbiota | Clinical Trials | Clareo Health

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COMPLETEDPhase 4NCT02471560

Tecfidera and the Gut Microbiota

The primary objective of the study is to determine if dimethyl fumarate (DMF) causes changes in the abundance and diversity of commensal microbiota. The secondary objectives of this study are as follo...

Lead sponsor: Biogen•7 locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Biogen

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•Have a confirmed diagnosis of RRMS and satisfy the therapeutic indication as described in the local label.
•Female subjects of childbearing potential who are not surgically sterile must practice effective contraception according to the summary of product characteristics (SPC) during their participation in the study and be willing and able to continue contraception for 30 days after their last dose of study treatment.

Exclusion Criteria

•Diagnosis of primary progressive, secondary progressive or progressive relapsing MS.
•Antibiotic treatment in the last month prior to study entry.
•Scheduled alteration of diet, including the use of probiotics.

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: September 5, 2021Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE4

Enrollment36

Start dateNov 2015

Last updatedSep 5, 2021

Condition

Multiple Sclerosis, Relapsing-Remitting

Locations shown

Research site

Drammen

Research site

Haukeland

Research Site

Lillehammer

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 5, 2021Data synced to Clareo: June 28, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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