Statins for Crohn's Disease

Overseen By Touran Fardeen

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Stanford University

Must not be taking: Cyclosporine, Antifungals, Fibrates, others

Disqualifiers: Pregnancy, Severe renal dysfunction, others

Compensation: Varies

Number of Visits: 2

Duration: 6-12 months

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether statins, typically used to lower cholesterol, can prevent strictures (narrowing of the intestines) in individuals with Crohn's disease. Researchers aim to determine if statins reduce the formation of these strictures compared to a placebo, which contains no active ingredient. Participants will take either the statin rosuvastatin or a placebo daily for 6-12 months, with clinic visits and regular check-ins. Individuals with stricturing Crohn's disease scheduled for specific surgeries in California may be suitable for this trial. As an Early Phase 1 trial, this research focuses on understanding how rosuvastatin affects people with Crohn's disease, offering participants the opportunity to contribute to groundbreaking medical insights.

Will I have to stop taking my current medications?

The trial requires you to stop taking certain medications unless you have explicit clearance from your doctor. These include antifungals, fibrate drugs, macrolide antibiotics, protease inhibitors, calcium channel blockers, amiodarone, warfarin, and colchicine. If you are currently using cyclosporine or statins, you cannot participate in the trial.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that statins, such as rosuvastatin, are usually well-tolerated for various health issues. Studies have found that statins are linked to fewer surgeries and hospital visits in individuals with inflammatory bowel diseases (IBD), including Crohn's disease, suggesting they might be safe for these patients.

However, research on rosuvastatin specifically for Crohn's disease remains in the early stages, so detailed safety information for this use is limited. While statins can sometimes cause side effects like muscle pain, liver problems, or digestive issues, these are uncommon.

As rosuvastatin undergoes early-phase clinical trials for Crohn's disease, researchers are primarily assessing its safety for this specific use. Participants in this trial will help determine how well people tolerate rosuvastatin for Crohn's disease. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Crohn's disease?

Unlike the standard treatments for Crohn's Disease, which often include anti-inflammatory drugs, immune system suppressors, and biologics, rosuvastatin offers a unique approach by leveraging its cholesterol-lowering properties. This statin is known for its ability to reduce inflammation and improve endothelial function, which could be beneficial for managing Crohn's Disease symptoms. Additionally, rosuvastatin's well-established safety profile for treating high cholesterol makes it an intriguing candidate for repurposing in this new context. Researchers are excited about its potential to provide an alternative treatment option with a different mechanism of action compared to current therapies.

What evidence suggests that statins might be an effective treatment for Crohn's disease?

Research suggests that statins, such as rosuvastatin, might benefit people with Crohn's disease. Some studies have found that statin use links to a lower risk of developing Crohn's disease and fewer hospital visits for this condition. Specifically, rosuvastatin has been associated with lower death rates in patients with inflammatory bowel diseases, including Crohn's disease. However, earlier studies did not show significant changes in disease activity after short-term use. In this trial, participants will receive either rosuvastatin or a placebo to evaluate its potential benefits. Researchers hope that statins might help prevent the narrowing of the intestines, known as strictures, by reducing inflammation. ^{1 2 3 5 6}

Who Is on the Research Team?

Sidhartha R Sinha, MD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

Adults with a confirmed diagnosis of stricturing Crohn's disease, who are scheduled for surgical resection of terminal ileum strictures at Stanford University or Dr. Phillip Fleshner's practice in Los Angeles.

Inclusion Criteria

I have been diagnosed with stricturing Crohn's disease.

I am scheduled for surgery on my intestine at Stanford or Dr. Fleshner's in LA.

Exclusion Criteria

Pregnant, nursing, or planning to become pregnant in the next 6-12 months

Known clinical allergy or prior adverse reaction to statin therapy (e.g., rhabdomyolysis)

I am not taking specific medications like antifungals or antibiotics without my doctor's approval to join the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants take statins or placebo daily for 6-12 months, with dose adjustments based on tolerance

6-12 months

2 visits (in-person), monthly check-ins (phone call)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including post-surgery surveillance colonoscopy

6-12 months post surgery

What Are the Treatments Tested in This Trial?

Interventions

• Rosuvastatin

Trial Overview

The trial is testing if statins can prevent the formation of strictures in Crohn's disease patients compared to a placebo. Participants will take either statins or placebo daily for 6-12 months and have regular clinic visits, complete symptom questionnaires, and monthly phone check-ins.

How Is the Trial Designed?

Group I: Statin Experimental Treatment 1 Intervention

Rosuvastatin tablet(s) once daily for 6-12 months. Dose will start at 10 mg daily (5 mg daily for Asians), then increase to 20 mg for those tolerating and without contraindication.

Group II: Control Placebo Group 1 Intervention

Placebo tablet(s) taken once daily for 6-12 months.

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Published Research Related to This Trial

In a study involving 12,400 patients over 12,212 patient-years, rosuvastatin was found to have a safety profile similar to other statins, with adverse events occurring in 57.4% of patients, comparable to 56.8% in the placebo group.

Serious side effects like myopathy and significant liver or muscle enzyme elevations were very rare (less than 0.03% for myopathy), indicating that rosuvastatin is well tolerated among patients with dyslipidemia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of rosuvastatin. Shepherd, J., Hunninghake, DB., Stein, EA., et al.[2015]

Rosuvastatin, a commonly prescribed medication for high cholesterol, is generally safe but can lead to rare and serious side effects, such as ischaemic colitis.

In a case study of a 64-year-old woman, ischaemic colitis was diagnosed after starting rosuvastatin, and her symptoms resolved completely after discontinuing the drug, highlighting the need for awareness of this potential adverse reaction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse drug reaction: rosuvastatin as a cause for ischaemic colitis in a 64-year-old woman. Tan, J., Pretorius, CF., Flanagan, PV., et al.[2021]

In a study involving 30 female mice with colitis induced by DSS, both simvastatin and atorvastatin significantly reduced disease activity, with reductions of 64% and 76% respectively, compared to a 41% reduction in the control group.

The effectiveness of statins in modifying disease activity in this colitis model was found to be comparable to that of an anti-TNFalpha treatment, suggesting a potential therapeutic role for statins in inflammatory bowel disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Disease modifying effect of statins in dextran sulfate sodium model of mouse colitis. Kanagarajan, N., Nam, JH., Noah, ZA., et al.[2018]

Citations

1.

journals.lww.com

journals.lww.com/ajg/fulltext/2025/10002/s1622_comparative_effectiveness_of_statins_in.1622.aspx

S1622 Comparative Effectiveness of Statins in Inflammatory...

Among high-intensity statins, rosuvastatin was associated with significantly lower all-cause mortality compared to atorvastatin in IBD (HR 0.73, P < 0.001), CD ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8247597/

Association Between Statin Use and Inflammatory Bowel ...

Statin use was associated with a lower risk of CD, but not of UC. The association with CD risk appeared strongest for current statin use.

3.

academic.oup.com

academic.oup.com/ibdjournal/advance-article/doi/10.1093/ibd/izaf077/8120133

A Nationwide Cohort Study 2006-2020 | Inflammatory Bowel ...

Statins were associated with a reduced risk of IBD-related surgery, hospitalizations, and disease flares in patients with UC, and with a reduced risk of IBD- ...

4.

journals.lww.com

journals.lww.com/ajg/fulltext/2009/10003/statin_therapy_in_active_crohn_s_disease__1291.1291.aspx

Statin Therapy in Active Crohn's Disease

There were no significant differences in disease activity after 6 weeks of therapy with rosuvastatin or pravastatin as defined by HBI (rosuvastatin 10 v. 11.2, ...

5.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0953620520300613

Statins and inflammatory bowel disease: Where do we ...

Statin use may confer a protective effect in reducing the risk of new-onset IBD. Indeed, this study provides novel and intriguing insights into a potential ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10474364/

Statin use and risk of colorectal cancer in patients with ...

While further research is required to validate our findings, our data suggest that statins may lower the risk of CRC in patients with IBD.