Drug Repurposing - Statins as Microbiota Modulating Agents in Ulcerative Colitis

NCT ID: NCT04883840

Last Updated: 2025-11-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 177 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-22
• Study Completion Date: 2025-10-11

Brief Summary

• 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.

Conditions

Ulcerative Colitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo

Group Type: PLACEBO_COMPARATOR

Rosuvastatin 10mg

Intervention Type: DRUG

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).

Rosuvastatin 10 mg

Group Type: EXPERIMENTAL

Rosuvastatin 10mg

Intervention Type: DRUG

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).

Interventions

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).

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vlaams Instituut Biotechnologie (VIB)

UNKNOWN

Sponsor Role: collaborator

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Severine Vermeire, MD & PhD

Role: PRINCIPAL_INVESTIGATOR

KU/UZ Leuven

Jeroen Raes, PhD

Role: STUDY_DIRECTOR

KU Leuven/VIB

Locations

Imelda Ziekenhuis

Bonheiden, Antwerp, Belgium

UZ Leuven

Leuven, Vlaams-Brabant, Belgium

AZ Delta

Roeselare, West-Vlaanderen, Belgium

Countries

Belgium

Other Identifiers

S63190

Identifier Type: -

Identifier Source: org_study_id