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Completed

NCT Number: NCT02471560

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 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.

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Key information

Conditions

Multiple Sclerosis, Relapsing-Remitting Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Multiple Sclerosis Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Research site, Drammen, Norway

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

dimethyl fumarate

Drug

As per the prevailing local label.

Other names: DMF, Tecfidera, BG00012

injectable MS DMT

Drug

As described above.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Biogen

Industry

Registry information

Official study title

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

Acronym: TECONGUT

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jun 15, 2015
Registry last updated
Sep 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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