Drug Repurposing - Statins as Microbiota Modulating Agents in Ulcerative Colitis

Status: Terminated
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Belgium
Imelda Ziekenhuis
Bonheiden
UZ Leuven
Leuven
AZ Delta
Roeselare
Time Frame
Start Date: 2020-10-22
Completion Date: 2025-10-11
Participants
Target number of participants: 177
Treatments
Placebo_comparator: Placebo
Experimental: Rosuvastatin 10 mg
Sponsors
Collaborators: Vlaams Instituut Biotechnologie (VIB)
Leads: Universitaire Ziekenhuizen KU Leuven

This content was sourced from clinicaltrials.gov