Noninvasive Markers of Gluten Ingestion in Celiac Disease Patients
Completed · Not applicable · Has a placebo group
Conditions studied: Adult Form of Celiac Disease
In brief
This is a clinical trial to evaluate the sensitivity of noninvasive, novel markers of gluten ingestion in celiac disease patients who are following gluten free diet for at least a period of one year. These noninvasive markers may be helpful to monitor the silent intestinal damage, possibly resulting from the accidental consumption of gluten due to cross contamination of gluten free diet.
Key facts
- Study ID
- NCT02389062
- Run by
- Thomas Jefferson University
- People needed
- 5
- Starts
- 2015-02-11
- Expected to finish
- 2017-02-11
- Last updated by the study team
- 2019-07-19
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Thomas Jefferson University — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.