Crohn Disease · Crohn's Ileocolitis
Rosuvastatin to Prevent Recurrent Strictures After Crohn’s Disease Surgery
This randomized study asks whether daily rosuvastatin can reduce early signs of stricture recurrence after surgery in adults with stricturing Crohn’s disease, compared with placebo.
Registry title: Effect of Statins on Crohn's Disease
1 recruiting U.S. site ↓Study at a glance
- Age
- 18 Years–80 Years
- Treatment
- Rosuvastatin or Placebo
- Design
- Randomized · Double
- Central study contact
- Touran Fardeen650-736-5555tfardeen@stanford.edu
- Sponsor
- Stanford University
Research question
Among people undergoing surgery for stricturing Crohn’s disease, does rosuvastatin reduce short-term clinical and biological signs of stricture recurrence compared with placebo?
Participant snapshot
Who the study is looking for
- The study is looking for adults ages 18 through 80.
- The study is looking for people with an established diagnosis of stricturing Crohn’s disease.
- Participants must be scheduled for surgical removal of terminal ileum strictures.
- The scheduled surgery must be at Stanford University or Dr. Phillip Fleshner’s colorectal surgery practice in Los Angeles.
Participation overview
What participation may involve
Participants take rosuvastatin or placebo every day, attend two clinic visits for laboratory tests after starting treatment, complete symptom and medication questionnaires, respond to monthly telephone check-ins, and undergo a post-surgery surveillance colonoscopy assessment. What participation may involve: - Take rosuvastatin or placebo tablets once daily. - Visit the clinic twice for laboratory tests after starting rosuvastatin or placebo. - Complete questionnaires about symptoms and medications. - Respond to monthly check-ins by telephone during participation. - Have disease recurrence assessed using the Rutgeerts score at a post-surgery surveillance colonoscopy. The registry states that participants take the assigned tablets for 6 to 12 months. The registry reports two clinic visits for laboratory tests after treatment begins and monthly telephone check-ins, but it does not provide a complete visit schedule.
Study interventions
What participants may receive or do
- Rosuvastatin: Participants assigned to this group take rosuvastatin tablets once daily for 6 to 12 months. The registry states that dosing starts at 10 mg daily, or 5 mg daily for Asians, and may increase to 20 mg if tolerated and not contraindicated.
- Placebo: Participants assigned to the control group take placebo tablets once daily for 6 to 12 months. The registry describes the placebo as a look-alike substance containing no drug.
Study design
How the comparison works
This is an early Phase 1, parallel-group prevention study with an estimated 20 participants. Participants are assigned to daily rosuvastatin or placebo after surgery for a Crohn’s disease stricture. Assignment is random in a 2-to-1 ratio: about two-thirds of participants are assigned to rosuvastatin and one-third to placebo. The study is double-masked: participants and investigators are not told which intervention a participant receives. The control group takes placebo tablets once daily for 6 to 12 months. The placebo is described as a look-alike substance containing no drug. Randomization gives each participant an approximately one-in-three chance of assignment to placebo.
Reported activities
Procedures and tests
- Clinic laboratory tests are performed twice after participants begin rosuvastatin or placebo.
- Participants complete questionnaires about their symptoms and medications.
- Participants respond to monthly telephone check-ins.
- A post-surgery surveillance colonoscopy is used to assess the Rutgeerts score, which measures intestinal lesions and narrowing.
- The researchers plan clinical outcome assessment and immune, microbiome, and metabolic profiling.
Eligibility highlights
Details that may affect whether you contact the study
These are selected highlights, not a complete eligibility check. Exact criteria remain in the full registry record below.
Common requirements
- An established diagnosis of stricturing Crohn’s disease is required.
- The person must be scheduled for surgical removal of terminal ileum strictures.
- The qualifying surgery must be scheduled at Stanford University or Dr. Phillip Fleshner’s colorectal surgery practice in Los Angeles.
- The registry age range is 18 through 80 years.
Possible reasons someone may not be able to join
- People who are pregnant, nursing, or planning pregnancy during the next 6 to 12 months are excluded.
- Stage 5 chronic kidney disease or end-stage renal disease is exclusionary.
- A known statin allergy or previous adverse reaction to statin therapy, such as rhabdomyolysis, is exclusionary.
- Current cyclosporine use is exclusionary.
- Current statin therapy before the study begins is exclusionary.
- Active liver disease beyond metabolic dysfunction-associated steatotic liver disease, with unexplained persistent liver-enzyme elevations, is exclusionary.
- Use of certain antifungals, fibrates, macrolide antibiotics, protease inhibitors, calcium channel blockers, amiodarone, warfarin, or colchicine is exclusionary unless a treating physician explicitly clears enrollment.
Important unknowns
What the record does not make clear
- The registry reports two clinic visits for laboratory tests and monthly telephone check-ins but does not provide the complete schedule for screening, surgery-related assessments, colonoscopy, or other research activities.
- The registry does not state which Crohn’s disease treatments may continue, must change, or are prohibited during the study.
- Current statin therapy before study initiation is exclusionary, but the registry does not provide a washout interval or explain whether stopping a statin before screening could be considered.
- The registry does not describe rescue treatment or what happens if Crohn’s disease worsens or a stricture recurs during participation.
- A post-surgery surveillance colonoscopy is reported at 6 to 12 months, but preparation, biopsy or sampling requirements, and whether additional endoscopies are needed are not described.
- The registry does not state which study-related drugs, tests, procedures, or clinical services are paid for or billed to insurance.
- The registry does not report whether participants receive compensation.
- The registry does not report reimbursement or support for transportation, lodging, parking, or other travel expenses.
- Eligibility permits surgery at Stanford or a named Los Angeles practice, but the registry’s location list shows only Stanford as recruiting.
- The registry does not state whether rosuvastatin is available through the study after participation ends.
Before contacting the site
Questions for the study team
- What is the complete schedule of screening, clinic, surgery-related, telephone, colonoscopy, and sample-collection activities?
- Which Crohn’s disease treatments may continue during the study, and would any medicines need to be stopped or changed?
- What laboratory tests and immune, microbiome, or metabolic samples are collected, and how often?
- What happens if Crohn’s disease symptoms worsen, a stricture recurs, or rosuvastatin causes a problem during the study?
- Which study-related drugs, tests, procedures, and travel expenses are covered, and is compensation available?
- Is the Los Angeles surgical cohort currently enrolling, and where would its study visits and follow-up procedures occur?
Before changing care
Questions for your gastroenterologist
- How stable is my Crohn’s disease around the planned surgery, and what signs of recurrence would need prompt treatment?
- Would participation require changes to my current Crohn’s disease medicines, and how could those changes affect disease control?
- What approved treatment and monitoring options are available after stricture surgery outside this study?
- Do my kidney function, liver health, previous statin experience, or current medicines raise specific concerns about this study?
- How should my gastroenterology and surgical teams coordinate with the researchers if my symptoms or treatment needs change?
This plain-language digest is provided by the Aidy clinical trials API. It may omit details and is not medical advice or an eligibility decision. Review the full registry record and confirm details with the study team.
Source record
Full registry record
The sections below preserve the study information supplied through ClinicalTrials.gov, including complete descriptions, criteria, outcomes, and locations.
About this study
The goal of this clinical trial is to learn if statins work to prevent strictures in adults with Crohn's disease. The main question it aims to answer is: * Can statins reduce the formation of strictures in participants with stricturing Crohn's disease? Researchers will compare statins to a placebo (a look-a-like substance that contains no drug) to see if statins work to prevent strictures from forming. Participants will: * Take statins or a placebo every day for 6-12 months * Visit the clinic for lab tests twice after starting either statins or placebo * Complete questionnaires about symptoms and medications * Respond to monthly check-ins (via phone call) during participation
Strictures are a formidable complication of Crohn's disease (CD), with more than half of patients experiencing clinically significant bowel obstructions. Stricturing CD is a primary driver of morbidity and hospital admissions and is frequently associated with treatment failures. Moreover, it is estimated that nearly 50% of patients with CD will undergo bowel resection surgery within ten years of diagnosis, highlighting the severity and persistence of this issue for patients as well as the healthcare system. By modulating inflammatory and fibrotic pathways, the investigators posit that statins reduce primary stricture development and also recurrence after stricture resection. The investigators will assess the impact of statin therapy on early stricture recurrence in a pilot, randomized controlled clinical trial in patients undergoing stricture resection, evaluating both clinical outcomes and detailed immune, microbiome, and metabolic profiling. Through this effort, the investigators will determine if statins reduce clinical and biological signs of stricture recurrence in the short term.
Study design and administration
- Organization
- Stanford University
- Organization class
- Other
- Organization study ID
- 76686
- Lead sponsor
- Stanford University
- Sponsor class
- Other
- Enrollment type
- Estimated
- Allocation
- Randomized
- Intervention model
- Parallel
- Primary purpose
- Prevention
- Masking
- Double
- Who is masked
- Participant, Investigator
- Standard age groups
- Adult, Older Adult
Study arms
Experimental
Statin
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.
Interventions: Drug: Rosuvastatin
Placebo Comparator
Control
Placebo tablet(s) taken once daily for 6-12 months.
Interventions: Other: Placebo
Interventions
Drug
Rosuvastatin
Rosuvastatin provided at 10 mg start; 5mg for Asians. Dose will be increased to 20 mg for those tolerating and without contraindication.
Other
Placebo
Placebo tablet(s)
Eligibility
18 Years–80 Years
All
Not accepted
Inclusion criteria (4)
- Established diagnosis of stricturing Crohn's diseaseRegistry-derived · unreviewed
- Scheduled for surgical resection of terminal ileum strictures at eitherRegistry-derived · unreviewed
- Stanford University, orRegistry-derived · unreviewed
- Dr. Phillip Fleshner's colorectal surgery practice in Los AngelesRegistry-derived · unreviewed
Exclusion criteria (15)
- Pregnant, nursing, or planning to become pregnant in the next 6-12 monthsRegistry-derived · unreviewed
- Severe renal dysfunction (stage 5 chronic kidney disease (CKD), end-stage renal disease (ESRD))Registry-derived · unreviewed
- Known clinical allergy or prior adverse reaction to statin therapy (e.g., rhabdomyolysis)Registry-derived · unreviewed
- Current use of cyclosporineRegistry-derived · unreviewed
- Current use of statin therapy prior to study initiationRegistry-derived · unreviewed
- Clinical diagnosis of active liver disease (beyond metabolic dysfunction-associated steatotic liver disease (MASLD)) with unexplained persistent elevations in hepatic transaminase levelsRegistry-derived · unreviewed
- Current use of any of the following medications, without explicit clearance from a treating physician to enroll in the study:Registry-derived · unreviewed
- Antifungals (e.g., ketoconazole, itraconazole, voriconazole)Registry-derived · unreviewed
- Fibrate drugsRegistry-derived · unreviewed
- Macrolide antibiotics (e.g., erythromycin, clarithromycin)Registry-derived · unreviewed
- Protease inhibitors (e.g., ritonavir, lopinavir)Registry-derived · unreviewed
- Calcium channel blockers (e.g., verapamil, diltiazem)Registry-derived · unreviewed
- AmiodaroneRegistry-derived · unreviewed
- WarfarinRegistry-derived · unreviewed
- ColchicineRegistry-derived · unreviewed
This information can identify a possible match, conflict, or item needing confirmation. Only the study team can determine eligibility.
Study outcomes
Primary outcome
Rutgeerts score
Time frame: 6-12 months post surgery
Will be assessed at post surgery surveillance colonoscopy. Minimum score is i0 (no lesions) and maximum score is i4 (diffuse inflammation with already larger ulcers, nodules and/or narrowing), with higher scores meaning a worse outcome.
Recruiting locations in the United States
Stanford University
RecruitingStanford, California, 94305, United States
Sidhartha Sinha, MD650-736-5555sidsinha@stanford.edu
Sidhartha Sinha, MD
Central study contacts
Registry dates
- First posted
- Aug 6, 2024
- Primary completion
- Oct 31, 2027
- Overall completion
- Oct 31, 2028
Trial information comes from ClinicalTrials.gov and may change. Confirm current status, eligibility, and site details with the study team. Aidy does not provide medical advice or determine eligibility.