Tecfidera and the Gut Microbiota

Biogen36 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Multiple Sclerosis, Relapsing-Remitting

Interventions

dimethyl fumarateDRUG

As per the prevailing local label.

injectable MS DMTDRUG

As described above.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (7)

Research site

Drammen, Norway

Research site

Haukeland, Norway

Research Site

Lillehammer, Norway

Research site

Lørenskog, Norway

Outcomes

Primary Outcomes

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

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.

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.

Time frame: 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

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

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.