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Trial record 10 of 24 for:    celiac | Recruiting, Not yet recruiting, Available Studies | United States

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 : April 20, 2018
Sponsor:
Collaborator:
Glutenostics, LLC
Information provided by (Responsible Party):
Jocelyn Silvester, Boston Children's Hospital

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.

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

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 and stool 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 and stool at home to receive immediate results. 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
Allocation: Randomized
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Celiac Disease
U.S. FDA Resources

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 5 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 5 to week 30, participants will be contacted a total of 6 times at random intervals to collect and test urine and stool samples and complete a questionnaire. 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 5 to week 30 of the study, participants will be contacted a total of 6 times at random intervals, instructed to collect stool and 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.



Primary Outcome Measures :
  1. Difference in frequency of gluten exposure in open results vs blinded groups following randomization. [ Time Frame: Weeks 5 to 30 ]
    Gluten exposure frequency is defined as the average per individual subject post-randomization percentage of samples collected between weeks 5 and 30 with detectable gluten immunogenic peptides using the qualitative assay (Gluten Detective)


Secondary Outcome Measures :
  1. Difference in quantity of mean gluten exposure following randomization in blinded vs. open results groups [ Time Frame: weeks 5 - 30 ]
    Mean gluten exposure is defined as the average per individual subject post-randomization concentration of gluten immunogenic peptides detected using the quantitative assay

  2. 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

  3. Change in symptom score in blinded vs. open results group [ Time Frame: weeks 5 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 5) and the end of the study period (week 30) will be calculated arithmetically.

  4. Change in celiac disease specific quality of life as measured by Celiac Disease DUX (CDDUX) in blinded vs. open results groups [ Time Frame: weeks 5 and 30 ]
    The CDDUX is a disease specific quality of life instrument for children with celiac disease.

  5. 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 5 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.



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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
Contact: Jocelyn A Silvester, MD PhD 617-355-6058 Jocelyn.Silvester@childrens.harvard.edu
Contact: Zackary J Hintze, BA 617-355-8881 celiacresearch@childrens.harvard.edu

Locations
United States, Massachusetts
Boston Children's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Boston Children’s Hospital
Glutenostics, LLC
Investigators
Principal Investigator: Jocelyn A Silvester, MD PhD Boston Children's Hospital, Beth Israel Deaconess Medical Center
  Study Documents (Full-Text)

Documents provided by Jocelyn Silvester, Boston Children's Hospital:
Study Protocol  [PDF] April 3, 2018
Informed Consent Form  [PDF] April 3, 2018


Publications:
Comino I, Fernández-Bañares F, Esteve M, Ortigosa L, Castillejo G, Fambuena B, Ribes-Koninckx C, Sierra C, Rodríguez-Herrera A, Salazar JC, Caunedo Á, Marugán-Miguelsanz JM, Garrote JA, Vivas S, Lo Iacono O, Nuñez A, Vaquero L, Vegas AM, Crespo L, Fernández-Salazar L, Arranz E, Jiménez-García VA, Antonio Montes-Cano M, Espín B, Galera A, Valverde J, Girón FJ, Bolonio M, Millán A, Cerezo FM, Guajardo C, Alberto JR, Rosinach M, Segura V, León F, Marinich J, Muñoz-Suano A, Romero-Gómez M, Cebolla Á, 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.

Responsible Party: Jocelyn Silvester, Instructor, Boston Children's Hospital
ClinicalTrials.gov Identifier: NCT03462979     History of Changes
Other Study ID Numbers: P00024698
First Posted: March 13, 2018    Key Record Dates
Last Update Posted: April 20, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jocelyn Silvester, Boston Children's Hospital:
Gluten-free diet
Urine
Stool
home testing

Additional relevant MeSH terms:
Celiac Disease
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Malabsorption Syndromes
Metabolic Diseases