- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03462979
Effects of Home Gluten Immunogenic Peptide Testing on Children With Celiac Disease
GlPs Improve Practice (GIP) at Home: Effects of Home Gluten Immunogenic Peptide Testing on Children With Celiac Disease
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02115
- Boston Children's Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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 Names:
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
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
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
|
weeks 8 - 30
|
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
|
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.
|
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
Time Frame: weeks 8 and 30
|
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
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.
|
weeks 8 and 30
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jocelyn A Silvester, MD PhD, Boston Children's Hospital, Beth Israel Deaconess Medical Center
Publications and helpful links
General Publications
- Moreno ML, Cebolla A, Munoz-Suano A, Carrillo-Carrion C, Comino I, Pizarro A, Leon F, Rodriguez-Herrera A, Sousa C. Detection of gluten immunogenic peptides in the urine of patients with coeliac disease reveals transgressions in the gluten-free diet and incomplete mucosal healing. Gut. 2017 Feb;66(2):250-257. doi: 10.1136/gutjnl-2015-310148. Epub 2015 Nov 25.
- Comino I, Real A, Vivas S, Siglez MA, Caminero A, Nistal E, Casqueiro J, Rodriguez-Herrera A, Cebolla A, Sousa C. Monitoring of gluten-free diet compliance in celiac patients by assessment of gliadin 33-mer equivalent epitopes in feces. Am J Clin Nutr. 2012 Mar;95(3):670-7. doi: 10.3945/ajcn.111.026708. Epub 2012 Jan 18.
- Comino I, Fernandez-Banares F, Esteve M, Ortigosa L, Castillejo G, Fambuena B, Ribes-Koninckx C, Sierra C, Rodriguez-Herrera A, Salazar JC, Caunedo A, Marugan-Miguelsanz JM, Garrote JA, Vivas S, Lo Iacono O, Nunez A, Vaquero L, Vegas AM, Crespo L, Fernandez-Salazar L, Arranz E, Jimenez-Garcia VA, Antonio Montes-Cano M, Espin B, Galera A, Valverde J, Giron FJ, Bolonio M, Millan A, Cerezo FM, Guajardo C, Alberto JR, Rosinach M, Segura V, Leon F, Marinich J, Munoz-Suano A, Romero-Gomez M, Cebolla A, Sousa C. Fecal Gluten Peptides Reveal Limitations of Serological Tests and Food Questionnaires for Monitoring Gluten-Free Diet in Celiac Disease Patients. Am J Gastroenterol. 2016 Oct;111(10):1456-1465. doi: 10.1038/ajg.2016.439. Epub 2016 Sep 20. Erratum In: Am J Gastroenterol. 2017 Jul;112(7):1208.
- Shan L, Molberg O, Parrot I, Hausch F, Filiz F, Gray GM, Sollid LM, Khosla C. Structural basis for gluten intolerance in celiac sprue. Science. 2002 Sep 27;297(5590):2275-9. doi: 10.1126/science.1074129.
- Moron B, Bethune MT, Comino I, Manyani H, Ferragud M, Lopez MC, Cebolla A, Khosla C, Sousa C. Toward the assessment of food toxicity for celiac patients: characterization of monoclonal antibodies to a main immunogenic gluten peptide. PLoS One. 2008 May 28;3(5):e2294. doi: 10.1371/journal.pone.0002294.
- van Doorn RK, Winkler LM, Zwinderman KH, Mearin ML, Koopman HM. CDDUX: a disease-specific health-related quality-of-life questionnaire for children with celiac disease. J Pediatr Gastroenterol Nutr. 2008 Aug;47(2):147-52. doi: 10.1097/MPG.0b013e31815ef87d.
- Varni JW, Burwinkle TM, Seid M. The PedsQL 4.0 as a school population health measure: feasibility, reliability, and validity. Qual Life Res. 2006 Mar;15(2):203-15. doi: 10.1007/s11136-005-1388-z.
- Silvester JA, Graff LA, Rigaux L, Walker JR, Duerksen DR. Symptomatic suspected gluten exposure is common among patients with coeliac disease on a gluten-free diet. Aliment Pharmacol Ther. 2016 Sep;44(6):612-9. doi: 10.1111/apt.13725. Epub 2016 Jul 22.
- Lebwohl B, Sanders DS, Green PHR. Coeliac disease. Lancet. 2018 Jan 6;391(10115):70-81. doi: 10.1016/S0140-6736(17)31796-8. Epub 2017 Jul 28.
- Ludvigsson JF, Ciacci C, Green PH, Kaukinen K, Korponay-Szabo IR, Kurppa K, Murray JA, Lundin KEA, Maki MJ, Popp A, Reilly NR, Rodriguez-Herrera A, Sanders DS, Schuppan D, Sleet S, Taavela J, Voorhees K, Walker MM, Leffler DA. Outcome measures in coeliac disease trials: the Tampere recommendations. Gut. 2018 Aug;67(8):1410-1424. doi: 10.1136/gutjnl-2017-314853. Epub 2018 Feb 13.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P00024698
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Quality of Life
-
B. Braun Medical SAUnknownQuality of Life of Colostomized Patient
-
Children's National Research InstituteRecruitingProfessional Quality of LifeUnited States
-
Istituto Ortopedico RizzoliUniversity of BolognaRecruitingImprove Quality of LifeItaly
-
Assiut UniversityUnknownImproving Quality of LifeEgypt
-
Region VästmanlandUnknownHealth Related Quality of Life
-
Ain Shams UniversityCompletedHealth Related Quality of LifeEgypt
-
Institute of Oncology LjubljanaUnknownHealth-related Quality of LifeSlovenia
-
Oslo University HospitalNorwegian Fund for Postgraduate Training in PhysiotherapyCompletedHealth-Related Quality of LifeNorway
-
Mattu UniversityCompletedBreif Description: Patients' Quality of Life ofEthiopia
-
Linkoeping UniversityRecruiting
Clinical Trials on Immunochromatographic lateral flow test
-
National Institute of Respiratory Diseases, MexicoHospital General Dr. Manuel Gea González; National Institute of Medical Sciences... and other collaboratorsNot yet recruitingAcquired Immunodeficiency Syndrome | Cryptococcal Meningitis | Tuberculosis Infection | Histoplasmosis AIDSMexico
-
Alder Hey Children's NHS Foundation TrustCompletedSARS-CoV-2 InfectionUnited Kingdom
-
Technical University of MunichRecruitingProsthetic Joint Infection | Arthroplasty Complications | Prosthetic InfectionGermany
-
Institute of Tropical Medicine, BelgiumUniversity Hospital, Geneva; Institut National de Recherche Biomédicale. Kinshasa...CompletedNeurological Disorders | Bacterial Meningitis | Cryptococcal Meningitis | Neurosyphilis | Cerebral Malaria | Central Nervous System TuberculosisCongo, The Democratic Republic of the
-
CD DiagnosticsUnknownPeriprosthetic Joint InfectionUnited States
-
Hamad Medical CorporationCompleted
-
Medical University of GrazMedical University of Vienna; Medical University Innsbruck; Universitätsmedizin...CompletedInvasive Pulmonary AspergillosisAustria, Germany
-
Tuberculosis Clinical Diagnostics Research ConsortiumMakerere UniversityUnknownTuberculosis | Tuberculosis, Pulmonary | Tuberculosis, MiliaryUganda
-
Brimrose Technology CorporationInstitut Pasteur de Madagascar; Naval Health Research Center; Northern Arizona... and other collaboratorsRecruitingPlague | Plague, Bubonic | Plague, Pneumonic | Yersinia Pestis Plague | Yersinia Pestis; Bubo | Yersinia Pestis; Pneumonia | Yersinia Sepsis | Yersinia Pestis Infection | Bubo; Yersinia Pestis | Bubonic; Plague, Skin | Pneumonic PlagueUnited States, Madagascar
-
Tuberculosis Clinical Diagnostics Research ConsortiumUniversity of Cape TownUnknownTuberculosis | Tuberculosis, Pulmonary | Tuberculosis, MiliarySouth Africa