The effect of Tecfidera® (Dimethyl Fumarate) on the gut microbiota as a causal factor for GI associated adverse events.

Phase 1

• Conditions: multiple sclerosis; Therapeutic area: Diseases [C] - Injuries, poisonings, and occupational diseases [C21]

• Registration Number: EUCTR2015-001197-18-NO
• Lead Sponsor: Biogen Idec Norway

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-04-15
• Study Completion: 2017-06-12
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

Have a confirmed diagnosis of RRMS and satisfy the therapeutic indication as described in the local label.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 65
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

Diagnosis of primary progressive, secondary progressive, or progressive relapsing MS.
History of malignancy (except for basal cell carcinoma that had been completely excised prior to study entry), severe allergic or anaphylactic reactions or known drug hypersensitivity, abnormal laboratory results indicative of any significant disease, and/or a major disease that would preclude participation in a clinical trial.
Antibiotic treatment in the last month prior to study entry
Scheduled alteration of diet, including the use of probiotics.
The following gastrointestinal conditions: ongoing GI infection, known inflammatory bowel disease, previous intestinal surgery (resections, stoma etc).
6.Previously treated with teriflunomide, fingolimod, natalizumab, or alemtuzumab, or medication that potentially could affect the gut microbiota.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of the study is to determine if DMF causes changes in the commensal microbiota.;Secondary Objective: To identify if there are differences in the gut microbiota composition between patients that do or do not develop GI AEs, both pre- and post DMF treatment.<br>To examine if the resolution of GI symptoms in DMF treated patients is reflected in the gut microbiota.<br>;Primary end point(s): The primary endpoint of this study is changes in gut microbiota composition (alpha diversity, beta diversity, abundances of bacterial taxa on all taxonomic levels) in subjects pre vs. post DMF administration. ;Timepoint(s) of evaluation of this end point: At week 2 and at week 12

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The secondary endpoints for this study are as follows:<br>•Changes in the gut microbiota composition (alpha diversity, beta diversity, abundances of bacterial taxa on all taxonomic levels) between DMF treated patients that do or do not develop GI AEs. <br>Changes in gut microbiota composition (alpha diversity, beta diversity, abundances of bacterial taxa on all taxonomic levels) in subjects treated with DMF compared to patients treated with an alternative injectable MS DMT. <br>Baseline differences in the gut microbiota composition (alpha diversity, beta diversity, abundances of bacterial taxa on all taxonomic levels) between DMF treated patients that do or do not develop GI AEs. <br>Changes in the gut microbiota composition (alpha diversity, beta diversity, abundances of bacterial taxa on all taxonomic levels) of DMF treated patients after resolution of GI AEs vs. during GI AE occurrences.<br>;Timepoint(s) of evaluation of this end point: Week 2 and week 12