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

Overview

About this study

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

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Joseph Murray, M.D.

Open for enrollment

Contact information:

Carol Van Dyke CCRP

(507) 266-7842

VanDyke.Carol@mayo.edu

More information

Publications

Publications are currently not available
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CLS-20490570

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