Back to resultsTecfidera and the Gut Microbiota (TECONGUT)
Primary Purpose
Multiple Sclerosis, Relapsing-Remitting
Status
Completed
Phase
Phase 4
Locations
Norway
Study Type
Interventional
Intervention
dimethyl fumarate
injectable MS DMT
Sponsored by
About this trial
This is an interventional other trial for Multiple Sclerosis, Relapsing-Remitting focused on measuring Microbiota, DMF, Gastro intestinal, MS
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.
Sites / Locations
- Research site
- Research site
- Research Site
- Research site
- Research site
- Research site
- Research site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
dimethyl fumarate
injectable MS DMT
Arm Description
As prescribed by the Investigator according to the local Summary of Product Characteristics.
As prescribed by the Investigator according to the local Summary of Product Characteristics.
Outcomes
Primary Outcome Measures
Comparison of the change in gut microbiota composition in participants pre vs. post initiation of DMF treatment.
Secondary Outcome Measures
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.
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)
Baseline differences in the gut microbiota composition between DMF treated participants that do or do not develop GI AEs.
Changes in the gut microbiota composition of DMF treated participants after resolution of GI AEs vs. during GI AE occurrences.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02471560
Brief Title
Tecfidera and the Gut Microbiota
Acronym
TECONGUT
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
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
November 6, 2015 (Actual)
Primary Completion Date
June 12, 2017 (Actual)
Study Completion Date
June 12, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biogen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Relapsing-Remitting
Keywords
Microbiota, DMF, Gastro intestinal, MS
7. Study Design
Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
dimethyl fumarate
Arm Type
Experimental
Arm Description
As prescribed by the Investigator according to the local Summary of Product Characteristics.
Arm Title
injectable MS DMT
Arm Type
Active Comparator
Arm Description
As prescribed by the Investigator according to the local Summary of Product Characteristics.
Intervention Type
Drug
Intervention Name(s)
dimethyl fumarate
Other Intervention Name(s)
DMF, Tecfidera, BG00012
Intervention Description
As per the prevailing local label.
Intervention Type
Drug
Intervention Name(s)
injectable MS DMT
Intervention Description
As described above.
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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.
Description
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
Title
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
Title
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Biogen
Official's Role
Study Director
Facility Information:
Facility Name
Research site
City
Drammen
ZIP/Postal Code
3019
Country
Norway
Facility Name
Research site
City
Haukeland
ZIP/Postal Code
5021
Country
Norway
Facility Name
Research Site
City
Lillehammer
ZIP/Postal Code
2609
Country
Norway
Facility Name
Research site
City
Lørenskog
ZIP/Postal Code
1478
Country
Norway
Facility Name
Research site
City
Molde
ZIP/Postal Code
6412
Country
Norway
Facility Name
Research site
City
Oslo
ZIP/Postal Code
0450
Country
Norway
Facility Name
Research site
City
Stavanger
ZIP/Postal Code
4011
Country
Norway
12. IPD Sharing Statement
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Tecfidera and the Gut Microbiota
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