Relationship between statin use and inflammatory bowel disease: Exploring possible implications

Table 1 Collection of the principal clinical trials conducted on the use of statins in patients with inflammatory bowel disease

Trial (NCT)1	Disease/setting	Intervention	Design/phase	Main objective	Status
NCT00454545	Moderate active CD	Atorvastatin 80 mg once daily for 13 weeks	Open-label, single-arm pilot	Effect on CXCL10 and immune markers	Completed
NCT00599625	Active CD (add-on to standard therapy)	Pravastatin (6 weeks)	Pilot, non-randomized	Feasibility and exploratory anti-inflammatory effects	Completed
NCT06538649	Stricturing CD after ileal resection	Rosuvastatin 10-20 mg daily vs placebo, 6-12 months	Randomized, placebo-controlled (phase 1)	Prevention of post-surgical stricture recurrence; immune-microbiome-metabolic profiling	Active
NCT05561062	Mild-to-moderate UC	Atorvastatin 80 mg plus mesalazine vs placebo plus mesalazine, 6 months	Randomized, placebo-controlled (phase 2)	Change in partial Mayo score and inflammatory markers	Active
NCT05567068	Mild-to-moderate UC	Atorvastatin 80 mg plus mesalazine vs placebo plus mesalazine	Randomized, placebo-controlled (phase 2)	Change in SCCAI, IBDQ-32, and systemic inflammation	Completed
NCT04883840 (ReMiDy)	UC and CD (remission or mild activity)	Rosuvastatin 10 mg daily vs placebo, cross-over design	Randomized, double-blind (phase 2/3)	Modulation of Bacteroides 2 enterotype and microbiota-inflammation link	Terminated; results pending
NCT04767984	Long-standing UC with TP53 mutation, high CRC risk	Atorvastatin 40 mg daily for 12 months vs placebo	Randomized, placebo-controlled (phase 2)	Effect on mutant TP53, proliferation and apoptosis markers	Active
NCT05912387	PSC (often IBD-associated)	Rosuvastatin 12 weeks plus 2-week washout	Single arm (phase 1)	Multiomic profiling of bile acids, microbiome and metabolism	Active

¹All data are extracted from the HYPERLINK https://clinicaltrials.gov portal.

NCT: National clinical trial; CD: Crohn’s disease; UC: Ulcerative colitis; CRC: Colorectal cancer; PSC: Primary sclerosing cholangitis; IBD: Inflammatory bowel disease; SCCAI: Simple clinical colitis activity index; IBDQ-32: 32-item inflammatory bowel disease questionnaire.