Tecfidera and the Gut Microbiota

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

CompletedPhase 4Relapsing MSNCT024715602015-001197-18

What it found

No results found

We found no results in the registry or in papers.

This trial finished 9 years ago. We found no results in the registry or in any paper that cites it.

What was tested

Treatment tested

Compared with

  • injectable MS DMT

What it measured

Main measures

  • 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

  • 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.

Other measures (5)

  • 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.

    Day 1, Week 2, Week 12 and/or upon occurrence of GI symptoms outside of designated time points

    Bladder, bowel and sexual functionPain

  • 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

  • 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

  • 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

  • The secondary endpoints for this study are as follows:

Who could take part

Relapsing MS · 18 and over

Show the full criteria

Inclusion 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.

Exclusion criteria

Not separately supplied in the registry.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

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    History

      1. Started

        Nov 2015

      2. Main results due

        Jun 2017

      3. Finished

        Jun 2017

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