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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 : July 17, 2019
Sponsor:
Collaborator:
Glutenostics, LLC
Information provided by (Responsible Party):
Jocelyn Silvester, Boston Children’s Hospital

Tracking Information
First Submitted Date  ICMJE March 5, 2018
First Posted Date  ICMJE March 13, 2018
Last Update Posted Date July 17, 2019
Actual Study Start Date  ICMJE April 15, 2018
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 17, 2019)
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)
Original Primary Outcome Measures  ICMJE
 (submitted: March 9, 2018)
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)
Change History Complete list of historical versions of study NCT03462979 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 17, 2019)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 9, 2018)
  • 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
  • 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 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.
  • Change in celiac disease specific quality of life as measured by 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.
  • Change in health related quality of life as measured by PedsQL core 4.0 in blinded vs. open results groups [ Time Frame: weeks 5 and 30 ]
    The PedsQL 4.0 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Home Gluten Immunogenic Peptide Testing on Children With Celiac Disease
Official Title  ICMJE GlPs Improve Practice (GIP) at Home: Effects of Home Gluten Immunogenic Peptide Testing on Children With Celiac Disease
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE
  • 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
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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.
    Intervention: Device: Immunochromatographic lateral flow test
  • 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.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 9, 2018)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2023
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jocelyn A Silvester, MD PhD 617-355-6058 Jocelyn.Silvester@childrens.harvard.edu
Contact: Christopher X Wan, BS 617-355-8881 celiacresearch@childrens.harvard.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03462979
Other Study ID Numbers  ICMJE P00024698
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jocelyn Silvester, Boston Children’s Hospital
Study Sponsor  ICMJE Boston Children’s Hospital
Collaborators  ICMJE Glutenostics, LLC
Investigators  ICMJE
Principal Investigator: Jocelyn A Silvester, MD PhD Boston Children's Hospital, Beth Israel Deaconess Medical Center
PRS Account Boston Children’s Hospital
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP