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

NCT ID: NCT04272983

Last Updated: 2021-04-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 3070 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-05-01
• Study Completion Date: 2020-12-31

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.

Conditions

Celiac Disease in Children

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

I.M. Sechenov First Moscow State Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Svetlana Erdes, Ph.D

Role: STUDY_CHAIR

Sechenov First Moscow State Medical University

Locations

Erdes Svetlana

Moscow, , Russia

Countries

Russia

References

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.

Reference Type: BACKGROUND

PMID: 28316996 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30056445 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31936445 (View on PubMed)

Other Identifiers

16-15-10410

Identifier Type: -

Identifier Source: org_study_id