Effects of Home Gluten Immunogenic Peptide Testing on Children With Celiac Disease
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|ClinicalTrials.gov Identifier: NCT03462979|
Recruitment Status : Recruiting
First Posted : March 13, 2018
Last Update Posted : June 4, 2020
|Condition or disease||Intervention/treatment||Phase|
|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||Device: Immunochromatographic lateral flow test||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||GlPs Improve Practice (GIP) at Home: Effects of Home Gluten Immunogenic Peptide Testing on Children With Celiac Disease|
|Actual Study Start Date :||April 15, 2018|
|Estimated Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||December 31, 2023|
Experimental: Open Results with home testing
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
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)
Other Name: Gluten Detective
No Intervention: Blinded (sample collection only)
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.
- Difference in frequency of gluten exposure in open results vs blinded groups following randomization. [ Time Frame: 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)
- Difference in quantity of mean gluten exposure following randomization in blinded vs. open results groups [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03462979
|Contact: Jocelyn A Silvester, MD PhD||617-355-8880||Jocelyn.Silvester@childrens.harvard.edu|
|United States, Massachusetts|
|Boston Children's Hospital||Recruiting|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Jocelyn A Silvester, MD PhD||Boston Children's Hospital, Beth Israel Deaconess Medical Center|