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.
Conditions
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
Recruitment Status
Suspended
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.
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
Intervention
Intervention Type
Intervention Name
Device
Immunochromatographic lateral flow test
Phase
Not Applicable
Gender
All
Min Age
6 Years
Max Age
18 Years
Download Date
January 20, 2022
Principal Investigator
Jocelyn Silvester
Primary Contact Information
For more information on this trial, visit clinicaltrials.gov.
Contact
For more information and to contact the study team: