Drug Repurposing - Statins as Microbiota Modulating Agents in Ulcerative Colitis
- Registration Number
- NCT04883840
- Lead Sponsor
- Universitaire Ziekenhuizen KU Leuven
- Brief Summary
* Evaluation of the microbiota modulation away from inflammation associated microbiota profile Bacteroides2 (Bact2)
* Evaluation of the microbiota modulation potential of statins in Bact2- enterotyped, healthy volunteers and ulcerative colitis patients.
* Evaluation of the effect of microbiota modulation on disease activity in ulcerative colitis patients.
* Evaluation of reduced inflammatory parameters of participants involved in trial
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 220
-
General criteria
- Bact2 enterotyped one month before start of study intervention (at least 150 of enrolled participants must meet this 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
- Patients in remission (mayo score below 4) or with currently mild to moderate active ulcerative colitis (defined by Mayo score of 4-10), despite stable medication (8 weeks) and a Mayo endoscopic sub-score 2- 3 at week 0 Criteria specific to healthy Bact2 participants
- Individuals with no physician diagnosed diseases or disorders
-
General criteria
- Prior and/or ongoing use of statins before study start
- History of surgical intervention in gastrointestinal tract (appendectomies are allowed)
- Females who are pregnant or actively trying to become pregnant
- Individuals with active liver disease including unexplained persistent elevations of serum transaminases and any serum transaminases elevation exceeding three times the upper limit of normal (ULN)
- Lactose intolerance
- Pre-diabetic participants
- Personal or family history of hereditary muscular disorders
- Individuals with a history of or diagnosed with alcohol abuse Criteria specific to UC patients
- Other conditions leading to profound immunosuppression such as HIV, infectious diseases leading to immunosuppression, bone marrow malignancies, liver cirrhosis
- A diagnosis of Crohn's disease or indeterminate colitis
- Individuals with hypothyroidism
- Individuals with a diagnosis of diabetes mellitus
- Individuals with severe renal impairment (creatinine clearance <30 ml/min)
- Individuals with myopathy
- Participants who have taken antibiotics sometime in the past four months
- Use of antibiotics one month prior to week 0
- Steroid dependency and requiring >16mg Medrol (methyl prednisone) or equivalent two week before week 0 Criteria specific to healthy Bact2 participants
- Participants with family history of autoimmune chronic inflammatory diseases like multiple sclerosis, IBD, and rheumatoid arthritis
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Placebo Rosuvastatin 10mg - Rosuvastatin 10 mg Rosuvastatin 10mg -
- Primary Outcome Measures
Name Time Method UC Mayo Score 8 weeks Decrease P partial mayo by one point or stays in remission during experimental intervention when taking IMP
Systemic inflammatory measures 8 weeks significant and substantial change in hs-CRP when taking IMP
Local inflammatory measures 8 weeks significant and substantial change fecal calprotectin when taking IMP
- Secondary Outcome Measures
Name Time Method Significant change in gastrointestinal microbiome composition 8 weeks Change away from dysbiotic enterotype to eubiotic one when taking IMP
Trial Locations
- Locations (2)
Imelda Ziekenhuis
🇧🇪Bonheiden, Antwerp, Belgium
UZ Leuven
🇧🇪Leuven, Vlaams-Brabant, Belgium