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Clinical Trials/NCT04883840
NCT04883840TerminatedPhase 2

Drug Repurposing - Statins as Microbiota Modulating Agents in Ulcerative Colitis

Universitaire Ziekenhuizen KU Leuven3 sites in 1 country177 target enrollmentStarted: October 22, 2020Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Terminated
Enrollment
177
Locations
3
Primary Endpoint
Significant change in gastrointestinal microbiome composition
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
Double (Participant, Care Provider)

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

Placebo

Placebo Comparator

Intervention: Rosuvastatin 10mg (Drug)

Rosuvastatin 10 mg

Experimental

Intervention: Rosuvastatin 10mg (Drug)

Outcomes

Primary Outcomes

Significant change in gastrointestinal microbiome composition

Time Frame: 8 weeks

Change away from dysbiotic enterotype to eubiotic one when taking IMP

Secondary Outcomes

  • UC Mayo Score / CDAI(8 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (3)

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