Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||6 Years - 18 Years|
- - Age 6 to 18 years at study entry - Diagnosis of celiac disease based upon either 1.
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
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Boston Children's Hospital|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Jocelyn A Silvester, MD PhD|
|Principal Investigator Affiliation||Boston Children's Hospital, Beth Israel Deaconess Medical Center|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
|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|
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.
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.
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.
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)
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.