Noninvasive Markers of Gluten Ingestion in Celiac Disease Patients
Adult Form of Celiac Disease
About this trial
This is an interventional diagnostic trial for Adult Form of Celiac Disease
Eligibility Criteria
Inclusion Criteria:
- This study population will consist of patients with a prior diagnosis of celiac disease based on intestinal biopsy (Marsh score of 1-4) who report control of symptoms with adherence to gluten free diet(GFD) for at least one year and have a baseline IgA antibody to tissue transglutaminase(IgA-tTG) within the normal range.
Exclusion Criteria:
- Patients < 18 years of age
- Patients with refractory celiac disease (RFD), defined as persisting or recurring symptoms and mucosal villous atrophy, despite strict adherence to a gluten free diet (GFD) for >12 months and a negative IgA antibody to tissue transglutaminase (IgA-tTG)
- Patients with enteropathy-associated T-cell lymphoma
- Patients with IgA deficiency
- Patients with a diagnosis of inflammatory bowel disease, irritable bowel symptoms, or acute gastroenteritis
- Patients taking immunosuppressive medications
- Patients who are pregnant
- Patients who are breast feeding/lactating
Sites / Locations
- Thomas Jefferson University
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Placebo controlled group
High dose gluten capsules
Low dose gluten capsules
This is a group of same number of subjects as in other arms, who will be given equivalent dose of placebo- cornstarch capsules i.e 5 capsules containing neutral substance- cornstarch(placebo) to be taken daily by mouth for a period of 12 weeks.
This group of subjects will be given high dose i.e 2.5 g of gluten containing capsules, 5 capsules to be taken daily by mouth, for a period of 12 weeks.
This group of subjects will be given low dose i.e 0.5 g of gluten containing capsules, 5 capsules to be taken daily by mouth, for a period of 12 weeks.