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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