About the Trial
The T1D+CeD Research Study is a paid clinical trial for individuals diagnosed with both celiac disease (CeD) and type 1 diabetes (T1D).
The study is being conducted at Stanford University, Palo Alto, CA, and is researching whether an investigational medication can help reduce symptoms of accidental gluten exposure in such individuals.
A Dueling Dual Diagnosis
Celiac disease occurs 4 to 11 times more often in people diagnosed with type 1 diabetes than the general population.
In recent years, physicians have recommended that patients diagnosed with type 1 diabetes also be screened for celiac disease.
If you have been diagnosed with both conditions, you may have learned to make adjustments in your every day life. But eating can still be a challenging, misunderstood, and lonely struggle.
Though there are multiple ways to manage type 1 diabetes, there is only the one “treatment” for celiac disease: the gluten-free diet.
But what if the gluten-free diet is not enough?
A New Hope for a Unique Group
The study medication is called “latiglutenase” and is a combination of 2 enzymes specific for gluten. This means that, when eaten with a meal containing a small amount of gluten, latiglutenase breaks down gluten proteins.
The study medication is designed to be used alongside a gluten-free diet and reduce symptoms of accidental gluten exposure (a.k.a., cross-contamination or cross-contact).
If you are between 14-80 years old and diagnosed with both T1D and celiac disease*, joining the T1D+CeD Research Study offers the opportunity to try this investigational medication under the oversight of leading physician-researchers.
What happens during the T1D+CeD Study?
Screening: After passing the pre-screening period, you will be asked to provide medical records, undergo physical exams and a few lab tests, record your celiac-related symptoms, and complete other study activities over 2 months.
Completion: After completing all study visits (up to 8 visits over 34 weeks total) and assessments, you will have completed the study. Compensation is provided at the end of each visit.
Pre-screen: Complete the online pre-screener so our study team can determine if you are eligible to participate. If you are eligible, a study team member will reach out to you within a few days to verify eligibility.
Participation: After passing the screening period, you will come in for 5 more visits over 24 weeks to complete study assessments, including urine tests and HbA1C measurements. You will be provided masked study medication and also be asked to consume a study-provided snack weekly.
Study Results: The study is closed once the target number of study participants have enrolled and completed all study visits. When results are available, they will be published to ClinicalTrials.gov and/or in a peer-reviewed article by the collaborating institutions.
*Questions? Check out our FAQ
Additional inclusion and exclusion criteria apply
Diagnosed with both celiac disease and type 1 diabetes
Following a gluten-free diet for at least the past 12 months
Willing to occasionally eat a study-provided minimal gluten-containing snack less than once weekly for 28 weeks.
Between 14 and 80 years of age
Still experiencing at least moderate symptoms despite following a gluten-free diet
Willing and able to come to the research clinic for 8 visits over 34 weeks
If you meet the above criteria, you may qualify. Click below to start the pre-screener and get connected with a study team member to learn more.
See if you Qualify
These are our favorite resources from recognized organizations to learn more about celiac disease and T1D: