About the Study
Welcome to the CeliacShield Study website. This NIH-funded clinical research study has been designed to assess the investigational medication latiglutenase and its ability to relieve symptoms and protect the small intestine of celiac disease patients from gluten exposure. Latiglutenase consists of a combination of two enzymes which efficiently degrade gluten in the stomach when taken during meals.
As a study participant, you will be required to attend five in-person visits at the study site in Rochester, Minnesota over the course of 14 weeks. In addition, you will be asked to complete a daily electronic symptoms diary. You will be given gluten in the form of breadcrumbs (approximately one-half slice of bread) along with either the investigational medication or placebo at your evening meal for six consecutive weeks. The placebo resembles the investigational medication, but does not contain the active ingredients.
Participants will receive all study supplies, including the investigational medication as well as all study-related tests and procedures at no cost. Qualified participants may be reimbursed for study participation, including transportation costs. Please help advance a therapy for celiac patients by clicking the “See If You Pre-Qualify” button to learn more. Should you pre-qualify for the study, a study staff member will contact you and share additional study details as well as answer any of your questions.
For further information, refer to our study page on ClinicalTrials.gov.
You may qualify to participate if you:
Are between 18 and 80 years old
Have a confirmed diagnosis of celiac disease
Have been on a gluten-free diet for the last 12 months
Are not pregnant or actively looking to become pregnant
Have no history of drug or alcohol abuse in the last 12 months
Are willing to take gluten with daily evening meals for 6 consecutive weeks
Are willing to travel to the study site in Rochester, Minnesota for 5 study visits
Take our pre-screening survey to find out if you qualify. For questions or more information, please contact us.