Status:
TERMINATED
Study of Latiglutenase in T1D/CD Patients
Lead Sponsor:
Entero Therapeutics
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Immunogenics, LLC
Conditions:
Celiac Disease
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
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...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 6 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 19 2022
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT04839575
Start Date
April 6 2021
End Date
December 19 2022
Last Update
August 5 2024
Active Locations (1)
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1
Stanford University
Palo Alto, California, United States, 94306