Population Study of the Prevalence of Celiac Disease and Other Gluten-dependent Disorders in Children and Adolescents

Completed

• Conditions: Celiac Disease in Children

• Registration Number: NCT04272983
• Lead Sponsor: I.M. Sechenov First Moscow State Medical University

Brief Summary

To study the prevalence and clinical features of celiac disease in children to develop new treatment approaches and rehabilitation strategies.

Detailed Description

The purpose of this screening program is to identify people at high risk for developing celiac disease, which is due to the genetic intolerance of gluten - a protein found in wheat, rye and barley. When a person with celiac disease consumes gluten-containing foods, his immune system damages the mucous membrane of the small intestine. Inflammation develops and, as a result, the absorption of vitamins, minerals and other vital nutrients is disrupted. Studies have shown that timely diagnosis of celiac disease is important for the treatment or prevention of its complications. Left untreated, the disease can lead to impaired growth and development, diabetes, cancer, or other diseases. In Europe and the USA, celiac disease is a chronic disease that occurs in approximately one in 100 and one in 22 who have risk factors. There are frequent cases of an erased or low-symptom course of celiac disease. Unfortunately, ninety-seven percent of cases remain undiagnosed and, accordingly, do not receive proper treatment. A screening program will increase knowledge about the disease and contribute to the early detection of the disease.

Study Timeline

• Study Start: 2016-05-01
• Study First Submitted: 2020-02-13
• Study First Submitted QC: 2020-02-13
• Study First Posted: 2020-02-17
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Status Verified: 2021-03
• Last Update Submitted: 2021-04-09
• Last Update Posted: 2021-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3070

Inclusion Criteria

• Schoolchildren from various districts of Moscow selected as a result of questioning in the risk group for the development of celiac disease
• Availability of written informed consent of the child over 14 years of age to participate in the study;
• Availability of written informed consent of the parent of the child to participate in the study;
• Age from 7 to 18 years;
• Male and female gender;
• The number of points according to the results of the survey is more than 25.

Exclusion Criteria

• Age up to 7 years and over 18 years.
• The lack of written informed consent of the child over 14 years of age to participate in the study;
• The lack of written informed consent of the parent / guardian of the child to participate in the study;
• The number of points on the results of the survey from 0 to 24

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Serological and genetic studies at risk group	3 year	Serological and genetic testing in the laboratory. Screening for celiac disease for suspected celiac disease carried out by testing in an independent laboratory serological examinations (total IgA, AT to tissue transglutaminase IgA, AT to tissue transglutaminase IgG, AT to endomysium IgA); genetic screening - HLA-DQ2 / DQ8; IgE (wheat flour, F4).
Questioning of schoolchildren	2 year	Questionnaire by specially developed questionnaire. A structured questionnaire was used to collect data on symptoms and signs that are known to be associated with celiac disease. Each of the following statements begin with "Does your child have ...? " Scoring: Never=1; Seldom= 2; Frequent=3; A Lot=4; Don't Know=0; No=1; Yes=2 If the total score was 25 or more, then this respondent belongs to the high risk group for the development of celiac disease.

Trial Locations

Locations (1)

Erdes Svetlana; 🇷🇺 Moscow, Russian Federation