Tecfidera and the Gut Microbiota

Multiple Sclerosis, Relapsing-Remitting Clinical Trial

— TECONGUT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02471560
• Other study ID #: NOR-BGT-14-10665
• Secondary ID: 2015-001197-18
• Status: Completed
• Phase: Phase 4
• Start date: November 6, 2015
• Est. completion date: June 12, 2017

Study information

• Verified date: September 2021
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: June 12, 2017
• Est. primary completion date: June 12, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting

Intervention

Drug:
• dimethyl fumarate
As per the prevailing local label.
• injectable MS DMT
As described above.

Locations

Country	Name	City	State
Norway	Research site	Drammen
Norway	Research site	Haukeland
Norway	Research Site	Lillehammer
Norway	Research site	Lørenskog
Norway	Research site	Molde
Norway	Research site	Oslo
Norway	Research site	Stavanger

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of the change in gut microbiota composition in participants pre vs. post initiation of DMF treatment.		Day 1, Week 2, Week 12 and/or upon occurrence of GI symptoms outside of designated time points
Secondary	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.	Day 1, Week 2, Week 12 and/or upon occurrence of GI symptoms outside of designated time points
Secondary	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)		Day 1, Week 2, Week 12 and/or upon occurrence of GI symptoms outside of designated time points
Secondary	Baseline differences in the gut microbiota composition between DMF treated participants that do or do not develop GI AEs.		Day 1, Week 2, Week 12 and/or upon occurrence of GI symptoms outside of designated time points
Secondary	Changes in the gut microbiota composition of DMF treated participants after resolution of GI AEs vs. during GI AE occurrences.		Upon GI symptoms and week 12