Effects of Home Gluten Immunogenic Peptide Testing on Children With Celiac Disease
Celiac Disease, Gluten Sensitivity, Gluten Enteropathy
About this trial
This is an interventional supportive care trial for Celiac Disease focused on measuring Gluten-free diet, Urine, Stool, home testing
Eligibility Criteria
Inclusion Criteria:
- Age 6 to 18 years at study entry
Diagnosis of celiac disease based upon either
- Biopsy criteria i) Marsh 3 lesion and/or villous height:crypt depth ratio (Vh:Cd) < 3 with intraepithelial lymphocytosis; and ii) Elevated serum tTG IgA and/or EMA antibodies
- Serologic/genetic (ESPGHAN 2012) criteria i) Symptoms compatible with celiac disease; ii) Serum tTG IgA > 10 x upper limit of normal for assay; iii) EMA titre elevated on a separate sample; and iv) HLADQ genotype compatible with celiac disease.
- Adherence to a gluten-restricted diet (self-reported) for 6 months or more
- Attending a clinician assessment for celiac disease at Boston Children's Hospital
Exclusion Criteria:
- Unable to provide urine and/or stool sample or attend study visits
- English proficiency unsuitable for completion of surveys
- Anuria or oliguria
- Reliance upon commercial gluten-free formulas as primary source of nutrition
- Comorbid condition that in the opinion of the investigator would interfere with the subject's participation in the study or would confound the results of the study
Sites / Locations
- Boston Children's Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Open Results with home testing
Blinded (sample collection only)
Participants in the open results arm will be provided with Gluten Detective home testing kits (immunochromatographic lateral flow tests) at week 8 of the study for immediate qualitative (yes/no) feedback about the presence of biomarkers of gluten in their stool and/or urine. During the period from week 8 to week 30, participants will be contacted a total of 6 times at random intervals to collect and test urine samples and complete a questionnaire.Additionally, participants will be given 4 stool test kits, with instructions that they may use these at times of their choosing and will report results and reasons for test use, if any. During this time participants will also keep a diary of suspected gluten exposures. All samples collected will be returned during the week 30 study visit.
Participants in the blinded arms will not be given a test kit but will be given sample collection materials. During the period from week 8 to week 30 of the study, participants will be contacted a total of 6 times at random intervals, instructed to collect urine samples, and complete a questionnaire. Participants will also keep a diary of suspected gluten exposures. All samples collected will be returned during the week 30 study visit. After completion of sample collection, all participants will be unblinded and notified of the results once the samples have been processed.