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

Study of the Prevalence of Gluten-dependent Diseases in the Russian Population and the Development of New Biotechnological Approaches to Obtain Gluten-free Products

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04272983
Enrollment
3070
Registered
2020-02-17
Start date
2016-05-01
Completion date
2020-12-31
Last updated
2021-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Celiac Disease in Children

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.

Interventions

None listed

Sponsors

I.M. Sechenov First Moscow State Medical University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
7 Years to 18 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Questioning of schoolchildren2 yearQuestionnaire 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.
Serological and genetic studies at risk group3 yearSerological 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).

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026