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

Biogen Idec Norway0 个研究点目标入组 36 人开始时间: 2015年4月15日最近更新: 2022年4月19日

适应症

试验速览

暂无简介。

•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

•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.

发起方

Biogen Idec Norway