Study of Latiglutenase in T1D/CD Patients

Not Recruiting

Trial ID: NCT04839575

Purpose

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)

Eligibility

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 surgery)
* 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

Intervention(s):

drug: Latiglutenase

drug: Placebo

Not Recruiting

Contact Information

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