Prospective, Randomized, Double-Blind, Placebo-Controlled, Crossover Study in Symptomatic CD Patients

Clinical Trial ID: NCT04243551

Description

This is a phase 2b, multicenter, prospective, randomized, double-blind, placebo-controlled, crossover study in symptomatic celiac disease patients attempting a GFD for at least one year prior to screening.

This is a phase 2b, multicenter, prospective, randomized, double-blind, placebo-controlled, crossover study in symptomatic celiac disease patients attempting a GFD for at least one year prior to screening. Seropositive patients (blood test confirmed at Visit 0) will be scheduled for a Screening Visit (Visit 1) whereas seronegative patients will be discontinued from study participation (screen failures). Patients who meet Visit 1 protocol enrollment criteria will be enrolled and begin the first of two 5 week periods.


Criteria

Inclusion Criteria: - Biopsy confirmed CD 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: - Wheat allergy - History of peptic ulcer disease, esophagitis, IBS, IBD - Active colitis, dermatitis herpetiformis - Diagnosed with Type 1 Diabetes - Patients 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

  • Start Date

    2020-02-29

  • Last Updated

    2020-01-30

  • Sponsor

    National Institute of Allergy and Infectious Diseases (NIAID)

  • Condition Name

    Celiac Disease

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