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

Sponsor
I.M. Sechenov First Moscow State Medical University (Other)
Overall Status
Completed
CT.gov ID
NCT04272983
Collaborator
(none)
3,070
Enrollment
1
Location
56
Actual Duration (Months)
54.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    3070 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Study of the Prevalence of Gluten-dependent Diseases in the Russian Population and the Development of New Biotechnological Approaches to Obtain Gluten-free Products
    Actual Study Start Date :
    May 1, 2016
    Actual Primary Completion Date :
    Dec 31, 2020
    Actual Study Completion Date :
    Dec 31, 2020

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    2. 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).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    7 Years to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Erdes Svetlana Moscow Russian Federation

    Sponsors and Collaborators

    • I.M. Sechenov First Moscow State Medical University

    Investigators

    • Study Chair: Svetlana Erdes, Ph.D, Sechenov First Moscow State Medical University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    I.M. Sechenov First Moscow State Medical University
    ClinicalTrials.gov Identifier:
    NCT04272983
    Other Study ID Numbers:
    • 16-15-10410
    First Posted:
    Feb 17, 2020
    Last Update Posted:
    Apr 12, 2021
    Last Verified:
    Mar 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Celiac Disease

    Study Results

    No Results Posted as of Apr 12, 2021