Drug Repurposing - Statins as Microbiota Modulating Agents in Ulcerative Colitis

NCT04883840 | Terminated Phase 2 DMC

• 1 other identifier: S63190
• Study Type: interventional
• Target: 177
• Locations: 1 country
• Sites: 3

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

Keywords

Microbiome; Dysbiosis

Outcome Measures

Primary Outcomes (1)

• Significant change in gastrointestinal microbiome composition

  Change away from dysbiotic enterotype to eubiotic one when taking IMP

  8 weeks

Secondary Outcomes (1)

• UC Mayo Score / CDAI

  8 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Drug: Rosuvastatin 10mg

Rosuvastatin 10 mg

EXPERIMENTAL

Drug: Rosuvastatin 10mg

Interventions

Rosuvastatin 10mg 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).

Placebo; Rosuvastatin 10 mg

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• Vlaams Instituut Biotechnologie (VIB): collaborator

Study Sites (3)

Imelda Ziekenhuis

Bonheiden, Antwerp, 2820, Belgium

Location

UZ Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location

AZ Delta

Roeselare, West-Vlaanderen, 8800, Belgium

Location

MeSH Terms

Conditions

Colitis, Ulcerative; Dysbiosis

Interventions

Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Severine Vermeire, MD & PhD

  KU/UZ Leuven

  PRINCIPAL INVESTIGATOR

• Jeroen Raes, PhD

  KU Leuven/VIB

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2021
• First Posted: May 12, 2021
• Study Start: October 22, 2020
• Primary Completion: October 11, 2025
• Study Completion: October 11, 2025
• Last Updated: November 25, 2025

Record last verified: 2025-10

Locations

BE (3)