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Effects of Home Gluten Immunogenic Peptide Testing on Children With Celiac Disease

NCT03462979 · Status: SUSPENDED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2022-01-20

No results posted yet for this study

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.

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

Interventions

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)

Sponsors & Collaborators

Principal Investigators

  • Jocelyn A Silvester, MD PhD · Boston Children's Hospital, Beth Israel Deaconess Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-15
Primary Completion
2021-12-31
Completion
2023-12-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03462979 on ClinicalTrials.gov