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

NCT04272983 | Completed

• 1 other identifier: 16-15-10410
• Study Type: observational
• Target: 3,070
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Celiac Disease in Children

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Schoolchildren of the city of Moscow

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• I.M. Sechenov First Moscow State Medical University: lead

Study Sites (1)

Erdes Svetlana

Moscow, Russia

Location

Related Publications (3)

• 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.

  PMID: 28316996 BACKGROUND

• 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.

  PMID: 30056445 BACKGROUND

• 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.

  PMID: 31936445 BACKGROUND

Study Officials

• Svetlana Erdes, Ph.D

  Sechenov First Moscow State Medical University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2020
• First Posted: February 17, 2020
• Study Start: May 1, 2016
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: April 12, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)