Status:
SUSPENDED
Effects of Home Gluten Immunogenic Peptide Testing on Children With Celiac Disease
Lead Sponsor:
Boston Children's Hospital
Collaborating Sponsors:
Glutenostics, LLC
Conditions:
Celiac Disease
Gluten Sensitivity
Eligibility:
All Genders
6-18 years
Phase:
NA
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 res...
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' t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT03462979
Start Date
April 15 2018
End Date
December 31 2023
Last Update
January 20 2022
Active Locations (1)
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1
Boston Children's Hospital
Boston, Massachusetts, United States, 02115