Celiac Disease, Diagnostic Self Evaluation, Diet Modification, Digestive System Disease, Gastrointestinal Disease, Gluten Enteropathy, Gluten Sensitivity, Intestinal Disease, Malabsorption Syndromes, Patient Compliance, Quality of Life
Conditions
Keywords
Gluten-free diet, Urine, Stool, home testing
Brief summary
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
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.
Interventions
DEVICEImmunochromatographic lateral flow test
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)
Sponsors
Glutenostics, LLC
Boston Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Age 6 to 18 years at study entry * Diagnosis of celiac disease based upon either 1. 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 2. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in frequency of gluten exposure in open results vs blinded groups following randomization. | Weeks 8 to 30 | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference in quantity of mean gluten exposure following randomization in blinded vs. open results groups | weeks 8 - 30 | Mean gluten exposure is defined as the average per individual subject post-randomization concentration of gluten immunogenic peptides detected using the quantitative assay |
| Celiac disease symptom score in blinded vs. open results group at the end of the study | Week 30 | Symptom score (using the Celiac Disease PedsRO or ObsRO as appropriate for age) at week 30 |
| Change in symptom score in blinded vs. open results group | weeks 8 and 30 | 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. |
| Change in celiac disease specific quality of life as measured by Celiac Disease DUX (CDDUX) in blinded vs. open results groups | weeks 8 and 30 | The CDDUX is a disease specific quality of life instrument for children with celiac disease. |
| Change in pediatric health related quality of life as measured by PedsQL 4.0 generic core scale in blinded vs. open results groups | weeks 8 and 30 | 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. |
Countries
United States
Outcome results
None listed