Effects of Home Gluten Immunogenic Peptide Testing on Children With Celiac Disease

A vizsgálat adatai

Ki végzi

Boston Children's Hospital

Azonosító

NCT03462979

A regiszteradat frissítve

2022. január 20.

Eredeti leírás

This study aims to investigate how knowledge of gluten immunogenic peptide (GIP) levels in stool and urine affects subsequent adherence to a gluten-free diet. Half of the participants will receive results in real-time using a home device and the other half will store samples to be tested at the end of the 30 week study. Participants will also have a diet review with a dietitian at the beginning of the end of their study and be asked questions about their symptoms, gluten-free diet adherence and quality of life.A teljes eredeti leírásKevesebb

GlPs Improve Practice (GIP) at Home: Effects of Home Gluten Immunogenic Peptide Testing on Children With Celiac Disease

This study aims to investigate how knowledge of gluten immunogenic peptide (GIP) levels in stool and urine affects subsequent adherence to a gluten-free diet. Half of the participants will receive results in real-time using a home device and the other half will store samples to be tested at the end of the 30 week study. Participants will also have a diet review with a dietitian at the beginning of the end of their study and be asked questions about their symptoms, gluten-free diet adherence and quality of life.

Bevonási feltételek: 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.

Kizáró feltételek: 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; 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.

ClinicalTrials.gov NCT03462979