Drug Repurposing - Statins as Microbiota Modulating Agents in Ulcerative Colitis

Launched by UNIVERSITAIRE ZIEKENHUIZEN KU LEUVEN · May 6, 2021

Keywords

ClinConnect Summary

This clinical trial is studying the potential benefits of using statins, commonly known as cholesterol-lowering medications, to change the gut bacteria profile in people with ulcerative colitis, a condition that causes inflammation in the intestines. Researchers want to see if these changes can help reduce inflammation and improve symptoms in patients with mild to moderate ulcerative colitis, as well as in healthy individuals with a specific type of gut bacteria known as Bacteroides2 (Bact2).

To participate, individuals need to be between 18 and 70 years old and have the Bact2 gut bacteria profile. Patients should either be in remission or have mild to moderate active ulcerative colitis, while healthy participants should not have any known diseases. Participants will receive treatment and be monitored for changes in their gut bacteria and overall health. It's important to note that certain individuals, such as those who have used statins previously or have specific health conditions, may not be eligible for this trial. If you're interested in learning more or considering participation, please reach out to the study team for further details.

Gender

ALL

Eligibility 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