Drug Repurposing - Statins as Microbiota Modulating Agents in Ulcerative Colitis (ReMiDy)

• Evaluation of the microbiota modulation away from inflammation associated microbiota profile Bacteroides2 (Bact2)
• Evaluation of the effect of microbiota modulation on disease activity in ulcerative colitis and Crohn's disease patients.

Study Overview

• Status: Terminated
• Conditions: Ulcerative Colitis
• Intervention / Treatment: Drug: Rosuvastatin 10mg

• Study Type: Interventional
• Enrollment (Actual): 177
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Belgium
  • Antwerp
    • Bonheiden, Antwerp, Belgium, 2820
      • Imelda Ziekenhuis
  • Vlaams-Brabant
    • Leuven, Vlaams-Brabant, Belgium, 3000
      • UZ Leuven
  • West-Vlaanderen
    • Roeselare, West-Vlaanderen, Belgium, 8800
      • Az Delta

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion criteria

General criteria Willingness to participate in the study and to sign the informed consent (Dutch) Between 18 and 70 years old Access to a -20°C freezer

Criteria specific to UC patients In clinical remission (total Mayo Score below 4) or with currently mild to moderate active ulcerative colitis (Mayo Score between 4-10 and endoscopic sub score 2-3 at week 0), either untreated or under stable medication

Criteria specific to CD patients In clinical remission (CDAI score below 150 at week 0) or with currently mild active Crohn's disease (CDAI score between 150-220 at week 0), either untreated or under stable medication

Exclusion criteria

General criteria Prior and/or ongoing use of statins Females who are pregnant, actively trying to become pregnant, or are not using effective anticonception measures Active liver disease or liver damage including unexplained persistent elevations of serum transaminases and any serum transaminases elevation exceeding three times the upper limit of normal (ULN) Prediabetes Personal or family history of or diagnosed with hereditary muscular disorders History of or diagnosed with alcohol abuse Use of antibiotics at any time in the four weeks before the start of the intervention (UC & CD patients Participation in simultaneously occurring clinical trials

Criteria specific to CD & UC patients Any surgical intervention in the gastrointestinal tract (with the exception of an appendectomy in all participants or ileocecal resections, cholecystectomy, fistulectomy, strictureplasty and abscess drainage in CD patients.) Severe renal impairment (creatinine clearance <30 ml/min) Diabetes mellitus Hypothyroidism Myopathy Other conditions leading to profound immunosuppression such as HIV, infectious diseases, bone marrow malignancies, and liver cirrhosis Use of methotrexate or calcineurin inhibitors Indeterminate colitis Steroid dependency, i.e., requiring more than 16mg Medrol (methyl prednisone) or an equivalent steroid two weeks before week 0

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Rosuvastatin 10mg; Daily dose of one medication over 8 week period then switch to another medication over an 8 week period (type of medication during each intervention period is blinded and then randomized).
Experimental: Rosuvastatin 10 mg	Drug: Rosuvastatin 10mg; Daily dose of one medication over 8 week period then switch to another medication over an 8 week period (type of medication during each intervention period is blinded and then randomized).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Significant change in gastrointestinal microbiome composition	Change away from dysbiotic enterotype to eubiotic one when taking IMP	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
UC Mayo Score / CDAI	Significant improvement in UC patient overall disease status characterised by reduction of at least 3 points in the non-invasive Mayo Score and by a full point reduction in the endoscopic subscore. Similarly, significant improvement in CD patient overall disease status characterised by reduction of the Crohn's disease activity index (CDAI) by at least 70 points or by a CDAI score < 150	8 weeks

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Collaborators: Vlaams Instituut Biotechnologie (VIB)
• Investigators: Principal Investigator: Severine Vermeire, MD & PhD, KU/UZ Leuven; Study Director: Jeroen Raes, PhD, KU Leuven/VIB

Study record dates

Study Major Dates

• Study Start (Actual): October 22, 2020
• Primary Completion (Actual): October 11, 2025
• Study Completion (Actual): October 11, 2025

Study Registration Dates

• First Submitted: May 6, 2021
• First Submitted That Met QC Criteria: May 6, 2021
• First Posted (Actual): May 12, 2021

Study Record Updates

• Last Update Posted (Estimated): November 25, 2025
• Last Update Submitted That Met QC Criteria: November 19, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Microbiome; Dysbiosis
• Additional Relevant MeSH Terms: Pathologic Processes; Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Colitis; Pathological Conditions, Signs and Symptoms; Colitis, Ulcerative; Dysbiosis; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Hydrocarbons; Amides; Pyrimidines; Hydrocarbons, Halogenated; Sulfonamides; Sulfones; Fluorobenzenes; Hydrocarbons, Fluorinated; Rosuvastatin Calcium
• Other Study ID Numbers: S63190

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No