Crohn's IleocolitisEarly Phase 1NCT06538649
Effect of Statins on Crohn's Disease
A Early Phase 1 study testing Rosuvastatin in people with Crohn's Ileocolitis and Crohn Disease, run by Stanford University at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Crohn's Ileocolitis, Crohn Disease
- What is being tested?
- Rosuvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Dec 2024to 31 Oct 2028
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Established diagnosis of stricturing Crohn's disease
- Scheduled for surgical resection of terminal ileum strictures at either
- Stanford University, or
- Dr. Phillip Fleshner's colorectal surgery practice in Los Angeles
Who cannot join
- Pregnant, nursing, or planning to become pregnant in the next 6-12 months
- Severe renal dysfunction (stage 5 chronic kidney disease (CKD), end-stage renal disease (ESRD))
- Known clinical allergy or prior adverse reaction to statin therapy (e.g., rhabdomyolysis)
- Current use of cyclosporine
- Current use of statin therapy prior to study initiation
- Clinical diagnosis of active liver disease (beyond metabolic dysfunction-associated steatotic liver disease (MASLD)) with unexplained persistent elevations in hepatic transaminase levels
Show all 15Show fewer
- Current use of any of the following medications, without explicit clearance from a treating physician to enroll in the study:
- Antifungals (e.g., ketoconazole, itraconazole, voriconazole)
- Fibrate drugs
- Macrolide antibiotics (e.g., erythromycin, clarithromycin)
- Protease inhibitors (e.g., ritonavir, lopinavir)
- Calcium channel blockers (e.g., verapamil, diltiazem)
- Amiodarone
- Warfarin
- Colchicine
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Stanford University
Stanford, California, 94305
Sidhartha Sinha, MD, 650-736-5555, sidsinha@stanford.edu
Sidhartha Sinha, MD
About this study
Official title: Determining the Therapeutic Potential of Statins on Stricturing Crohn's Disease
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
Read the detailed description
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.
- Conditions
- Crohn's Ileocolitis, Crohn Disease
- Being tested
- Rosuvastatin, Placebo
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RosuvastatinDrug
Also called Crestor
Rosuvastatin provided at 10 mg start; 5mg for Asians. Dose will be increased to 20 mg for those tolerating and without contraindication.
PlaceboOther
Placebo tablet(s)
| Study group | Role | What they receive |
|---|---|---|
| Statin | Experimental | 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. Receives: Drug: Rosuvastatin |
| Control | Placebo comparator | Placebo tablet(s) taken once daily for 6-12 months. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rutgeerts score
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.
Measured: 6-12 months post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2024
- Study start12 Dec 2024
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's IleocolitisStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Random assignment (2:1) to either statin (Arm 1) or placebo (Arm 2), such that 2/3 of participants will be assigned to Arm 1, and 1/3 of participants will be assigned to Arm 2.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sidhartha Ranjit Sinha, Stanford University
- Investigators
- Sidhartha R Sinha, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06538649
- Sponsor's protocol ID
- 76686
- Status last verified
- Feb 2026
- First submitted
- 1 Aug 2024
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Therapeutic Potential of Statins on Stricturing Crohn's Disease
- ClinicalTrials.gov ID
- NCT06538649
- Acronym / sponsor ID
- 76686
- Conditions
- Crohn's Ileocolitis, Crohn Disease
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 12 Dec 2024 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Oct 2028 (estimated)
- First posted
- 6 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Random assignment (2:1) to either statin (Arm 1) or placebo (Arm 2), such that 2/3 of participants will be assigned to Arm 1, and 1/3 of participants will be assigned to Arm 2.
| Arm | Type | Receives |
|---|---|---|
| Statin | Experimental | Drug: RosuvastatinRosuvastatin 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. |
| Control | Placebo comparator | Other: PlaceboPlacebo tablet(s) taken once daily for 6-12 months. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Established diagnosis of stricturing Crohn's disease
- Scheduled for surgical resection of terminal ileum strictures at either
Key exclusion criteria (15 listed)
- Pregnant, nursing, or planning to become pregnant in the next 6-12 months
- Severe renal dysfunction (stage 5 chronic kidney disease (CKD), end-stage renal disease (ESRD))
- Known clinical allergy or prior adverse reaction to statin therapy (e.g., rhabdomyolysis)
- Current use of cyclosporine
- Current use of statin therapy prior to study initiation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RosuvastatinAlso: CrestorRosuvastatin provided at 10 mg start; 5mg for Asians. Dose will be increased to 20 mg for those tolerating and without contraindication. | Drug | Statin |
| PlaceboPlacebo tablet(s) | Other | Control |
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Crohn's Ileocolitis
RecruitingObservational study
Family Members at INcreased-risk for Developing Inflammatory Bowel Disease
Inflammatory Bowel Disease (IBD), Ulcerative Colitis (UC)
Recruiting
Personalized Risk Estimation for Crohn's Disease (PRE-Crohn's): Implementation and Feasibility
Inflammatory Bowel Diseases, Crohn Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sidhartha R Sinha, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Rosuvastatin in people with Crohn's Ileocolitis and Crohn Disease, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Touran Fardeen (650-736-5555, tfardeen@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rutgeerts score (time frame: 6-12 months post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.