Tecfidera and the Gut Microbiota (TECONGUT)

September 3, 2021 updated by: Biogen

The Effect of Tecfidera® (Dimethyl Fumarate, BG00012) on the Gut Microbiota as a Causal Factor for Gastro Intestinal Associated Adverse Events.

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 follows: To identify if there are differences in the gut microbiota composition between patients that do or do not develop gastro intestinal (GI) adverse events (AEs), both pre- and post DMF treatment and to examine if the resolution of GI AEs in DMF treated patients is reflected in the gut microbiota.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Drammen, Norway, 3019
        • Research Site
      • Haukeland, Norway, 5021
        • Research Site
      • Lillehammer, Norway, 2609
        • Research Site
      • Lørenskog, Norway, 1478
        • Research Site
      • Molde, Norway, 6412
        • Research Site
      • Oslo, Norway, 0450
        • Research Site
      • Stavanger, Norway, 4011
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Key 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.

Key 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.

NOTE: Other protocol defined inclusion/exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: dimethyl fumarate
As prescribed by the Investigator according to the local Summary of Product Characteristics.
Drug: dimethyl fumarate
As per the prevailing local label.
Other Names:
  • BG00012
  • DMF
  • Tecfidera
Active Comparator: injectable MS DMT
As prescribed by the Investigator according to the local Summary of Product Characteristics.
Drug: injectable MS DMT
As described above.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Comparison of the change in gut microbiota composition in participants pre vs. post initiation of DMF treatment.
Time Frame: Day 1, Week 2, Week 12 and/or upon occurrence of GI symptoms outside of designated time points
Day 1, Week 2, Week 12 and/or upon occurrence of GI symptoms outside of designated time points

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in gut microbiota composition between DMF treated participants that do or do not develop GI AEs as measured by an increase in the Gastrointestinal Symptom Rating Scale (GSRS) score.
Time Frame: Day 1, Week 2, Week 12 and/or upon occurrence of GI symptoms outside of designated time points
GSRS is a self-reported questionnaire regarding GI symptoms comprising 15 items scored on a 7-point Likert scale. The 15 items can be grouped in 5 dimensions 1) abdominal pain (abdominal pain, gastric hunger pain, and nausea) 2) reflux (heartburn and acid regurgitation) 3) indigestion (borborygmus, bloating, eructation, and increased flatus) 4) diarrhea (diarrhea, loose stools, and urgency) and 5) constipation (constipation, hard stools, incomplete evacuation). A GI AE will be defined as an at least 2 point (>=2) increase from baseline in total score of any of the 5 dimensions in the GSRS.
Day 1, Week 2, Week 12 and/or upon occurrence of GI symptoms outside of designated time points
Changes in gut microbiota composition in participants treated with DMF compared to participants treated with an alternative injectable multiple sclerosis (MS) disease modifying therapies (DMT)
Time Frame: Day 1, Week 2, Week 12 and/or upon occurrence of GI symptoms outside of designated time points
Day 1, Week 2, Week 12 and/or upon occurrence of GI symptoms outside of designated time points
Baseline differences in the gut microbiota composition between DMF treated participants that do or do not develop GI AEs.
Time Frame: Day 1, Week 2, Week 12 and/or upon occurrence of GI symptoms outside of designated time points
Day 1, Week 2, Week 12 and/or upon occurrence of GI symptoms outside of designated time points
Changes in the gut microbiota composition of DMF treated participants after resolution of GI AEs vs. during GI AE occurrences.
Time Frame: Upon GI symptoms and week 12
Upon GI symptoms and week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biogen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 6, 2015

Primary Completion (Actual)

June 12, 2017

Study Completion (Actual)

June 12, 2017

Study Registration Dates

First Submitted

June 11, 2015

First Submitted That Met QC Criteria

June 11, 2015

First Posted (Estimate)

June 15, 2015

Study Record Updates

Last Update Posted (Actual)

September 5, 2021

Last Update Submitted That Met QC Criteria

September 3, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NOR-BGT-14-10665
  • 2015-001197-18 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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