Drug Repurposing - Statins as Microbiota Modulating Agents in Ulcerative Colitis

• Status: Recruiting
• Trial end date: 2022-12-22
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Universitaire Ziekenhuizen Leuven
• Collaborator: Vlaams Instituut Biotechnologie (VIB)
• Treatments: Rosuvastatin Calcium

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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