Clinical trial NCT02471560: Tecfidera and the Gut Microbiota
Official title: The Effect of Tecfidera® (Dimethyl Fumarate, BG00012) on the Gut Microbiota as a Causal Factor for Gastro Intestinal Associated Adverse Events.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Multiple Sclerosis, Relapsing-Remitting
Keywords: Microbiota
DMF
Gastro intestinal
MS
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2015-06-15
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Comparison of the change in gut microbiota composition in participants pre vs. post initiation of DMF treatment.
timeFrame: Day 1, Week 2, Week 12 and/or upon occurrence of GI symptoms outside of designated time points
Secondary outcomes:
measure: 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.
timeFrame: Day 1, Week 2, Week 12 and/or upon occurrence of GI symptoms outside of designated time points
measure: 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)
timeFrame: Day 1, Week 2, Week 12 and/or upon occurrence of GI symptoms outside of designated time points
measure: Baseline differences in the gut microbiota composition between DMF treated participants that do or do not develop GI AEs.
timeFrame: Day 1, Week 2, Week 12 and/or upon occurrence of GI symptoms outside of designated time points
measure: Changes in the gut microbiota composition of DMF treated participants after resolution of GI AEs vs. during GI AE occurrences.
timeFrame: Upon GI symptoms and week 12
Other outcomes:
Locations:
city: Drammen
country: Norway
facility: Research site
city: Haukeland
country: Norway
facility: Research site
city: Lillehammer
country: Norway
facility: Research Site
city: Lørenskog
country: Norway
facility: Research site
city: Molde
country: Norway
facility: Research site
city: Oslo
country: Norway
facility: Research site
city: Stavanger
country: Norway
facility: Research site
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References: