drugset / Trial / NCT02471560

Tecfidera and the Gut Microbiota

NCT02471560

Phase 4 Completed 36 enrolled Biogen
Non-randomizedParallel-groupOpen-labelOther

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.

Timeline

Start
2015-11-06
Primary completion
2017-06-12
Completion
2017-06-12

Drugs

EvaluationDrugModalityDoseRoute
Subject dimethyl fumarate Unknown