Status:
TERMINATED
Drug Repurposing - Statins as Microbiota Modulating Agents in Ulcerative Colitis
Lead Sponsor:
Universitaire Ziekenhuizen KU Leuven
Collaborating Sponsors:
Vlaams Instituut Biotechnologie (VIB)
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
PHASE3
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 ulcerativ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 22 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 11 2025
Estimated Enrollment :
177 Patients enrolled
Trial Details
Trial ID
NCT04883840
Start Date
October 22 2020
End Date
October 11 2025
Last Update
November 25 2025
Active Locations (3)
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1
Imelda Ziekenhuis
Bonheiden, Antwerp, Belgium, 2820
2
UZ Leuven
Leuven, Vlaams-Brabant, Belgium, 3000
3
AZ Delta
Roeselare, West-Vlaanderen, Belgium, 8800