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

Quality of Life Clinical Trial

Official title: GlPs Improve Practice (GIP) at Home: Effects of Home Gluten Immunogenic Peptide Testing on Children With Celiac Disease

Status Suspended

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Celiac Disease
• Diagnostic Self Evaluation
• Diet Modification
• Digestive System Disease
• Digestive System Diseases
• Gastrointestinal Disease
• Gastrointestinal Diseases
• Gluten Enteropathy
• Gluten Sensitivity
• Intestinal Disease
• Intestinal Diseases
• Malabsorption Syndromes
• Patient Compliance
• Quality of Life

• NCT number: NCT03462979
• Study type: Interventional
• Source: Boston Children's Hospital
• Status: Suspended
• Phase: N/A
• Start date: April 15, 2018
• Completion date: December 31, 2023