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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 23 November 2020
Main ID:  EUCTR2019-004208-37-BE
Date of registration: 04/03/2020
Prospective Registration: Yes
Primary sponsor: UZ Leuven
Public title: Statins for treating ulcerative colitis through GI microbiome
Scientific title: Drug repurposing - Statins as microbiota modulating agents in ulcerative colitis - ReMiDy
Date of first enrolment: 03/08/2020
Target sample size: 400
Recruitment status: Authorised-recruitment may be ongoing or finished
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2019-004208-37
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: no
Cross over: yes
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
Number of treatment arms in the trial: 2
 
Phase:  Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no
Countries of recruitment
Belgium
Contacts
Name: Clinical Trials Information   
Address:  49 Herestraat 3000 Leuven Belgium
Telephone:
Email: remidy@kuleuven.be
Affiliation:  KU Leuven
Name: Clinical Trials Information   
Address:  49 Herestraat 3000 Leuven Belgium
Telephone:
Email: remidy@kuleuven.be
Affiliation:  KU Leuven
Key inclusion & exclusion criteria
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



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
There are two population groups, 20 healthy volunteers and at least 150 individuals diagnosed with mild/moderate active ulcerative colitis or are in remission.
Intervention(s)

Trade Name: Rosuvastatine EG
Product Name: rosuvastatin
Pharmaceutical Form: Tablet
INN or Proposed INN: rosuvastatin
Other descriptive name: ROSUVASTATIN CALCIUM
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)
Main Objective: • Evaluation of the microbiota modulation away from inflammation associated microbiota profile Bacteroides2 (Bact2)
• Evaluation of the microbiota modulation potential of statins in Bact2-enterotyped, healthy volunteers and ulcerative colitis patients.
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.
Secondary Objective: • Evaluation of the effect of microbiota modulation on disease activity in ulcerative colitis patients.
• Evaluation of reduced inflammatory parameters of participants involved in trial
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.
Secondary Outcome(s)
Secondary end point(s): In order to ensure that a significant number of ulcerative colitis participants improved in their disease state, a reduction of at least 1 point in their mayo endoscopic sub score and/or a general 3-point reduction of their total Mayo score. Inflammatory status local (faecal calprotectin) and systemically (hs-CRP) will be closely assessed in addition to other health parameters. Time point comparisons of these variables will be conducted with paired Wilcoxon tests with multiple testing correction. Mental outlook and response to treatment versus outlook with placebo, characterized by the RAND-36 in questionnaires will be conducted with fisher exact tests. Other lifestyle habits and alterations will be documented with questionnaires and used to account for confounders in the analyses.
Timepoint(s) of evaluation of this end point: The secondary endpoints 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 when the UC patient enters the study site for their flexible sigmoidoscopy.
Secondary ID(s)
S63190
Source(s) of Monetary Support
Fonds Wetenschappelijk Onderzoek - Vlaanderen (FWO)
Vlaamse Instituut Biotechnologie
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date: 03/08/2020
Contact:
Results
Results available:
Date Posted:
Date Completed:
URL:
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