Drug repurposing - Statins as microbiota modulating agents in ulcerative colitis - ReMiDy

Z Leuven0 个研究点目标入组 400 人开始时间: 2020年3月4日最近更新: 2020年11月23日

适应症

试验速览

暂无简介。

•General criteria
•Bact2 enterotyped one month before start of study intervention (at least 150 of enrolled participants must meet this criteria)
•Willingness to participate in the study and to sign the informed consent (Dutch)
•Between 18 and 75 years old
•Access to a -20°C freezer
•Criteria specific to UC patients
•Patients in remission (mayo score below 4) or with currently mild to moderate active ulcerative colitis (defined by Mayo score of 4-10), despite stable medication (8 weeks) and a Mayo endoscopic sub-score 2-3 at week 0
•Criteria specific to healthy Bact2 participants
•Individuals with no physician diagnosed diseases or disorders
•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 300
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 100

•General criteria
•Prior and/or ongoing use of statins before study start
•History of surgical intervention in gastrointestinal tract
•Females who are pregnant or actively trying to become pregnant
•Individuals with active liver disease including unexplained persistent elevations of serum transaminases and any serum transaminases elevation exceeding three times the upper limit of normal (ULN)
•Lactose intolerance
•Pre-diabetic participants
•Personal or family history of hereditary muscular disorders
•Individuals with a history of or diagnosed with alcohol abuse
•Criteria specific to UC patients
•Other conditions leading to profound immunosuppression such as HIV, infectious diseases leading to immunosuppression, bone marrow malignancies, liver cirrhosis
•A diagnosis of Crohn’s disease or indeterminate colitis
•Individuals with hypothyroidism
•Individuals with a diagnosis of diabetes mellitus
•Individuals with severe renal impairment (creatinine clearance <30 ml/min)
•Individuals with myopathy
•Participants who have taken antibiotics sometime in the past four months
•Use of antibiotics one month prior to week 0
•Steroid dependency and requiring >16mg Medrol (methyl prednisone) or equivalent two week before week 0
•Criteria specific to healthy Bact2 participants
•Participants with family history of autoimmune chronic inflammatory diseases like multiple sclerosis, IBD, and rheumatoid arthritis

发起方

Z Leuven