Celiac DiseaseEarly Phase 1NCT03011931
Simvastatin Metabolism as a Test for CD Activity (IRB 15-007568]
A Early Phase 1 study testing Simvastatin in people with Celiac Disease, run by Entero Therapeutics at 1 site in United States.
Trial summary
To study the correlation between simvastatin metabolism by the enterocyte and the histologic state of the intestine in treated celiac disease. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Celiac Disease
- What is being tested?
- Simvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to Feb 2019
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Gluten-free diet for at least 1 year
- Clinical endoscopy within the past month
- Biopsies must show no villous atrophy or villous blunting
- Villous height to crypt depth (VHCD) ratio measurement should be 2.5:1 or greater
Who cannot join
- 1st degree relative with Celiac Disease
- Positive tTG IgA, already on simvastatin or statin agent
- Unable to stop non-steroidal or anti-inflammatory drugs
- Prior history of GI surgery other than appendectomy or cholecystectomy
- Taking drugs know to inhibit or activate CYP3A4
- Unable to avoid food known to inhibit CYP3A4
- History of a reaction to statin drugs in the past
- Pregnant or nursing women
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Simvastatin Metabolism as a Test for Celiac Disease Activity
To study the correlation between simvastatin metabolism by the enterocyte and the histologic state of the intestine in treated celiac disease.
Read the detailed description
A cross sectional design incorporating subjects with active celiac disease and healed celiac disease (based on clinically-obtained biopsies); and healthy individuals.
- Conditions
- Celiac Disease
- Being tested
- Simvastatin
- Medical subject headings
- Celiac Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SimvastatinDrug
Also called Zocor
20 mg Simvastatin given, Blood draw, Urine collection, Celiac serology testing, DNA sampling, Dietary review
| Study group | Role | What they receive |
|---|---|---|
| Simvastatin | Experimental | Simvastatin tablet, 20 mg, one time by mouth Receives: Drug: Simvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare simvastatin metabolism with intestinal biopsies
Measured: Within one month of visit
Secondary outcomes (5)
Villous height and crypt depth
As measured in intestinal biopsies
Measured: Within 1 month of visit
Dietary interview
To determine whether the patient is strictly adherent, mostly adherent or non-adherent to a gluten-free diet
Measured: At initial visit
Urinalysis
Looking for traces of gluten peptides
Measured: Prior to administration of simvastatin and at the 3-hour mark
Serologic testing
tTG IgA titer level determination
Measured: Prior to administration of simvastatin
DNA sampling
Genetic testing associated with celiac disease (DQ2 and DQ8)
Measured: Prior to administration of simvastatin
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2017 (estimated)
- Study startMar 2016
- Primary completionJan 2019
- Study completionFeb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Celiac DiseaseStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Entero Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Immunogenics, LLC
- Responsible party
- Sponsor
- Investigators
- Joseph A Murray, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03011931
- Sponsor's protocol ID
- 15-007568
- Status last verified
- Jan 2020
- First submitted
- 3 Oct 2016
- Last updated
- 5 Aug 2024
- 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 5 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simvastatin Metabolism as a Test for Celiac Disease Activity
- ClinicalTrials.gov ID
- NCT03011931
- Acronym / sponsor ID
- 15-007568
- Conditions
- Celiac Disease
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Entero TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- Immunogenics, LLC
- Study start
- Mar 2016
- Primary completion
- Jan 2019 (actual)
- Study completion
- Feb 2019 (actual)
- First posted
- 6 Jan 2017 (estimated)
- 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.
To study the correlation between simvastatin metabolism by the enterocyte and the histologic state of the intestine in treated celiac disease.
Detailed description
A cross sectional design incorporating subjects with active celiac disease and healed celiac disease (based on clinically-obtained biopsies); and healthy individuals.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Simvastatin | Experimental | Drug: SimvastatinSimvastatin tablet, 20 mg, one time by mouth |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Gluten-free diet for at least 1 year
- Clinical endoscopy within the past month
- Biopsies must show no villous atrophy or villous blunting
- Villous height to crypt depth (VHCD) ratio measurement should be 2.5:1 or greater
Key exclusion criteria (8 listed)
- 1st degree relative with Celiac Disease
- Positive tTG IgA, already on simvastatin or statin agent
- Unable to stop non-steroidal or anti-inflammatory drugs
- Prior history of GI surgery other than appendectomy or cholecystectomy
- Taking drugs know to inhibit or activate CYP3A4
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 |
|---|---|---|
| SimvastatinAlso: Zocor20 mg Simvastatin given, Blood draw, Urine collection, Celiac serology testing, DNA sampling, Dietary review | Drug | Simvastatin |
Primary outcome
Compare simvastatin metabolism with intestinal biopsies
Time frame: Within one month of visit
5 secondary outcomes
Villous height and crypt depth
Time frame: Within 1 month of visit
Dietary interview
Time frame: At initial visit
Urinalysis
Time frame: Prior to administration of simvastatin and at the 3-hour mark
Serologic testing
Time frame: Prior to administration of simvastatin
DNA sampling
Time frame: Prior to administration of simvastatin
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2024.
- A Study of Simvastatin Metabolism as a Test for Celiac Disease Activity - Mayo ClinicLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Celiac Disease
RecruitingObservational study
Celiac Disease Genomic Environmental Microbiome and Metabolomic Study
Celiac Disease
RecruitingObservational study
Pathogenic Study of Adult Immune Enteropathies
Celiac Disease, Autoimmune Enteropathy
Not yet recruitingObservational study
MENA/Levant Epidemiological, Registry of Immunological & Clinical Traits (MERIT)
Antiphospholipid (aPL)-Positive, Rheumatic Arthritis
Not yet recruitingObservational study
European Appleby Registry for Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma (PDAC)
Enrolling by invitation
Assessment of Nutritional Status in Celiac Disease Using Muscle Ultrasound in Pediatric Patients.
Celiac Disease in Children, Nutritional Assessment
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. This study is not recruiting at the moment.
Joseph A Murray, MD principal investigator
Mayo Clinic
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 Simvastatin in people with Celiac Disease, run by Entero Therapeutics 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 8 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: finished, as of the sponsor's last update on 5 Aug 2024. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare simvastatin metabolism with intestinal biopsies (time frame: Within one month of visit). 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 5 Aug 2024.