Clinical trial NCT04272983: Population Study of the Prevalence of Celiac Disease and Other Gluten-dependent Disorders in Children and Adolescents
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Celiac Disease in Children
Lead sponsor: I.M. Sechenov First Moscow State Medical University
Sponsor class: OTHER
First posted: 2020-02-17
Enrollment: 3070
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Schoolchildren of the city of Moscow

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.

Eligibility criteria: 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

Primary outcomes:
measure: Questioning of schoolchildren
timeFrame: 2 year
measure: Serological and genetic studies at risk group
timeFrame: 3 year
Secondary outcomes:
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Erdes Svetlana
Study officials:
affiliation: Sechenov First Moscow State Medical University
name: Svetlana Erdes, Ph.D
role: STUDY_CHAIR
References:
citation: Savvateeva LV, Erdes SI, Antishin AS, Zamyatnin AA Jr. Overview of Celiac Disease in Russia: Regional Data and Estimated Prevalence. J Immunol Res. 2017;2017:2314813. doi: 10.1155/2017/2314813. Epub 2017 Feb 20.
citation: Savvateeva LV, Erdes SI, Antishin AS, Zamyatnin AA Jr. Current Paediatric Coeliac Disease Screening Strategies and Relevance of Questionnaire Survey. Int Arch Allergy Immunol. 2018;177(4):370-380. doi: 10.1159/000491496. Epub 2018 Jul 27.
citation: Lototskaya PS, Manina MA, Tertychnyy AS, Zamyatnin AA Jr, Erdes SI. Duodenal Ulceration in a Child with Coeliac Disease. Diagnostics (Basel). 2020 Jan 9;10(1):31. doi: 10.3390/diagnostics10010031.