Clinical trial NCT03462979: Effects of Home Gluten Immunogenic Peptide Testing on Children With Celiac Disease
Official title: GlPs Improve Practice (GIP) at Home: Effects of Home Gluten Immunogenic Peptide Testing on Children With Celiac Disease
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: 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
Keywords: Gluten-free diet
Urine
Stool
home testing
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
Collaborators: name: Glutenostics, LLC
First posted: 2018-03-13
Enrollment: 120
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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

Primary outcomes:
measure: Difference in frequency of gluten exposure in open results vs blinded groups following randomization.
timeFrame: Weeks 8 to 30
Secondary outcomes:
measure: Difference in quantity of mean gluten exposure following randomization in blinded vs. open results groups
timeFrame: weeks 8 - 30
measure: Celiac disease symptom score in blinded vs. open results group at the end of the study
timeFrame: Week 30
measure: Change in symptom score in blinded vs. open results group
timeFrame: weeks 8 and 30
measure: Change in celiac disease specific quality of life as measured by Celiac Disease DUX (CDDUX) in blinded vs. open results groups
timeFrame: weeks 8 and 30
measure: Change in pediatric health related quality of life as measured by PedsQL 4.0 generic core scale in blinded vs. open results groups
timeFrame: weeks 8 and 30
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital, Beth Israel Deaconess Medical Center
name: Jocelyn A Silvester, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
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