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Assessment of Adherence to Gluten Free Diet in Children and Adolescents by Detection of Gluten in Faecal Samples.

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ClinicalTrials.gov Identifier: NCT03663309
Recruitment Status : Recruiting
First Posted : September 10, 2018
Last Update Posted : September 17, 2019
Sponsor:
Information provided by (Responsible Party):
raanan shamir, Rabin Medical Center

Brief Summary:
To assess the adherence to gluten free diet by measuring faecal and urinary gluten immunogenic peptides (GIP). This will provide an objective measure for adherence.

Condition or disease Intervention/treatment
Celiac Disease in Children Diagnostic Test: detecting Gluten peptides in faecal and urine samples

Detailed Description:
The adherence to the GFD can be assessed through a dietary interview performed by a registered dietitian or patient self-reports, mucosal healing, assessed by a small bowel biopsy or CD serological screening tests showing decreasing levels of antibodies. However, none of these methods offer an accurate measure of dietary compliance. A novel method to monitor the adherence to the GFD by detection of immune-dominant gluten peptides in human faeces or urine using the anti-α -gliadin G12 antibody was described recently in the literature. Gluten peptides, in particular peptides equivalent to the immunogenic - α -gliadin-33-mer peptide, are resistant to gastrointestinal digestion and that ensures a significant amount of the ingested gluten is excreted in faeces. Consequently, recovery of detectable amounts of the immunogenic fraction in faeces or urine indicates that gluten has passed through the digestive tract, and in the case of urine was absorbed, and, therefore, that gluten has been consumed .

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Assessment of Adherence to Gluten Free Diet in Children and Adolescents by Detection of Gluten Immunogenic Peptides in Faecal Samples and Nutritional Assessment. Retrospective Study
Actual Study Start Date : June 19, 2018
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
study group
  1. Children and adolescents aged 2-17 years, reported to be on gluten free diet for at least a year, diagnosed with celiac disease
  2. Children and adolescents aged 2-17 years that are reported to be noncompliant with gluten free diet, diagnosed with celiac disease for at least 1 year.
Diagnostic Test: detecting Gluten peptides in faecal and urine samples

At each visit patient will:

  • Bring 4-day food diary (attached)
  • Fill symptoms and complaints questionnaire (attached)
  • Provide 24 h diet recall in case a food diary absents
  • Fill Biagi score questionnaire (attached)
  • Perform blood test of TTG
  • Provide stool and urine samples

control group
Healthy controls aged 2-17 years old matched for age and sex.



Primary Outcome Measures :
  1. Correlation between fecal gluten peptides and nutritional assessment for gluten free diet, and correlation with celiac serology. [ Time Frame: one year ]
    Our goal is to examine which method will be the most accurate, nutritional assessment or laboratory tests for the adherence to GFD



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
  1. Children and adolescents aged 2-17 years, reported to be on gluten free diet for at least a year, diagnosed with celiac disease
  2. Children and adolescents aged 2-17 years that are reported to be noncompliant with gluten free diet, diagnosed with celiac disease for at least 1 year.
  3. Healthy controls aged 2-17 years old matched for age and sex.
Criteria

Inclusion Criteria:

  • Age 2-17 years.
  • Either diagnosis of celiac disease or, in controls, no systemic disease or inflammation
  • For all groups parents will provide informed consent.

Exclusion Criteria:

° Children with suspected or known inflammatory bowel disease or other gastrointestinal or systemic diseases.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03663309


Contacts
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Contact: Raanan Shamir, Prof. +972-3-9253672 raanan@shamirmd.com

Locations
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Israel
Schneider Children's Medical Center of Israel Recruiting
Petach Tikva, Israel, 49202
Sponsors and Collaborators
Rabin Medical Center
Investigators
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Study Chair: Liron Mondshine, B.Sc Rabin Medical Center
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Responsible Party: raanan shamir, Professor, Rabin Medical Center
ClinicalTrials.gov Identifier: NCT03663309    
Other Study ID Numbers: 0367-17RMC
First Posted: September 10, 2018    Key Record Dates
Last Update Posted: September 17, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Celiac Disease
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases