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

Study Overview
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Brief Summary
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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.

Detailed Description
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Following a gluten-free diet is difficult. Eating small amounts of gluten may be common. Gluten may cause a wide range of symptoms, or no symptoms at all. Thus, there is not always a 'feedback loop' to alert to accidental gluten exposure. Nevertheless, these silent gluten exposures may interfere with recovery and healing of the intestine. New tools are available to test for fragments of gluten - Gluten Immunogenic Peptides (GIPs) in urine and stool. The goal of this research study is to evaluate how knowledge of gluten-immunogenic peptide (GIP) levels in urine and stool affects subsequent adherence to a gluten-free diet. Participants will be children with celiac disease recruited at Boston Children's Hospital. All participants will undergo a diet assessment by a dietitian at the beginning and end of the study. At random intervals, participants will be prompted to collect their next urine sample and complete a survey related to symptoms and diet adherence. Half of the participants will store the sample to be tested later and the rest of the participants will be provided with devices to test their urine at home to receive immediate results. Participants in the home testing group will also be given a set of stool tests (x4) to use at their own discretion during the study period, and will report results and reasons for test use to the research team. GIP test results will be compared to other measures of celiac disease and gluten-free diet adherence, including antibody tests. These findings will help to determine how these new tools can be used to improve gluten-free diet adherence and symptoms and the effect on quality of life.

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

Conditions
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Celiac Disease, Gluten Sensitivity, Gluten Enteropathy, Gastrointestinal Disease, Digestive System Disease, Diet Modification, Intestinal Disease, Malabsorption Syndromes, Patient Compliance, Diagnostic Self Evaluation, Quality of Life

Intervention / Treatment
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* Device: Immunochromatographic lateral flow test


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Open Results with home testing<br>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. | Device: Immunochromatographic lateral flow test<br>* The immunochromatographic lateral flow test (Gluten Detective) is an at-home test that detects gluten immunogenic peptides excreted in stool or urine. This test can detect gluten exposures which occurred either during the last 24 hours (urine) or within up to a 7 day window (stool). Minimum intake amounts of gluten for successful detection using these test are 50mg (stool) to 500mg (urine)<br>* Other names: Gluten Detective;|
| No Intervention: Blinded (sample collection only)<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in frequency of gluten exposure in open results vs blinded groups following randomization. | Gluten exposure frequency is defined as the average per individual subject post-randomization percentage of samples collected between weeks 8 and 30 with detectable gluten immunogenic peptides using the qualitative assay (Gluten Detective) | Weeks 8 to 30 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in quantity of mean gluten exposure following randomization in blinded vs. open results groups | Mean gluten exposure is defined as the average per individual subject post-randomization concentration of gluten immunogenic peptides detected using the quantitative assay | weeks 8 - 30 | 
| Celiac disease symptom score in blinded vs. open results group at the end of the study | Symptom score (using the Celiac Disease PedsRO or ObsRO as appropriate for age) at week 30 | Week 30 | 
| Change in symptom score in blinded vs. open results group | Symptom score (using the Celiac Disease PedsRO or ObsRO as appropriate) and the change in symptom score between the end of the run-in period (week 8) and the end of the study period (week 30) will be calculated arithmetically. | weeks 8 and 30 | 
| Change in celiac disease specific quality of life as measured by Celiac Disease DUX (CDDUX) in blinded vs. open results groups | The CDDUX is a disease specific quality of life instrument for children with celiac disease. | weeks 8 and 30 | 
| Change in pediatric health related quality of life as measured by PedsQL 4.0 generic core scale in blinded vs. open results groups | The PedsQL 4.0 Generic Core is a validated pediatric general quality of life measure that is caregiver reported for younger children and both child and caregiver reported for older children. The score is scaled from 0 (lowest) to 100 (highest) with higher scores corresponding to better health related quality of life. | weeks 8 and 30 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gluten-free diet, Urine, Stool, home testing