Statins for treating ulcerative colitis through GI microbiome

Phase 1

• Conditions: There are two population groups, 20 healthy volunteers and at least 150 individuals diagnosed with mild/moderate active ulcerative colitis or are in remission.; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2019-004208-37-BE
• Lead Sponsor: Z Leuven

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-04
• Last Update Posted: 23 November 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: •Evaluation of the microbiota modulation away from inflammation associated microbiota profile Bacteroides2 (Bact2) <br>•Evaluation of the microbiota modulation potential of statins in Bact2-enterotyped, healthy volunteers and ulcerative colitis patients.;Secondary Objective: •Evaluation of the effect of microbiota modulation on disease activity in ulcerative colitis patients.<br>•Evaluation of reduced inflammatory parameters of participants involved in trial<br>;Primary end point(s): The primary endpoint of the trial is modulate at least 10% of those with Bact2 enterotype to a different enterotype and breaking the inflammatory cycle between the ulcerative colitis and pro-inflammatory microbes. ;Timepoint(s) of evaluation of this end point: Either at study site visit after the first period (week 8 + or - 3 days) or the second period (week 16 + or - 3 days) of intervention is complete. This depends whether the participant was randomized into the placebo or IMP first arms.