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Completed

NCT Number: NCT04272983

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

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

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Key information

Age range

7 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Erdes Svetlana

Moscow, Russia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Questioning of schoolchildren

    Time frame: 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

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

I.M. Sechenov First Moscow State Medical University

Other

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Feb 17, 2020
Registry last updated
Apr 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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