Study of Latiglutenase in T1D/CD Patients

Not Recruiting

Trial ID: NCT04839575


This is a phase 2, single-center prospective, double-blind, placebo-controlled, crossover study in Type 1 diabetes and celiac disease subjects attempting a GFD for at least one year prior to screening.

Official Title

Prospective, Double-Blind, Placebo-Controlled, Crossover Study of the Efficacy and Safety of Latiglutenase Treatment in Type 1 Diabetes Patients With Celiac Disease While Undergoing Periodic Gluten Exposure

Stanford Investigator(s)


Inclusion Criteria (select):

   - Confirmed CD diagnosis

   - Confirmed T1D diagnosis

   - Seropositive

   - Gluten free diet (12 months minimum)

   - Experienced at least one self-reported moderate or greater severity symptom during the
   last 28 day period

   - Willing to take study treatment daily

   - Must sign informed consent

Exclusion Criteria (select):

   - Wheat allergy

   - History of peptic ulcer disease, esophagitis, IBS, IBD

   - Active colitis

   - Subjects with known rapid gastric emptying (post-bariatric surgery, Billroth I or II

   - Chronic infectious gastrointestinal illness or acute infectious gastrointestinal
   illness within the 4 week period prior to screening

   - Known refractory celiac disease (RCD1 or RCD2)

   - Inability to give informed consent


drug: Latiglutenase

drug: Placebo

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305