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

Celiac Disease in Children Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04272983
• Other study ID #: 16-15-10410
• Status: Completed
• Start date: May 1, 2016
• Est. completion date: December 31, 2020

Study information

• Verified date: March 2021
• Source: I.M. Sechenov First Moscow State Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3070
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Celiac Disease
• Celiac Disease in Children

Locations

Country	Name	City	State
Russian Federation	Erdes Svetlana	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
I.M. Sechenov First Moscow State Medical University

Country where clinical trial is conducted

Russian Federation, 

References & Publications (3)

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). pii: E31. doi: 10.3390/diagnostics10010031. — View 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. Review. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Questioning of schoolchildren	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 year
Primary	Serological and genetic studies at risk group	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).	3 year