Celiac Disease in ChildrenNCT04272983
Population Study of the Prevalence of Celiac Disease and Other Gluten-dependent Disorders in Children and Adolescents
An observational study of Celiac Disease in Children, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.
Trial summary
To study the prevalence and clinical features of celiac disease in children to develop new treatment approaches and rehabilitation strategies. Read more about this study
- Who is it for?
- Ages 7 to 18 years
- Conditions the study is for
- Celiac Disease in Children
- How many people
- 3,070 participants
- Where
- 1 siteRussia
- Study dates
- 1 May 2016to 31 Dec 2020
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Schoolchildren of the city of Moscow
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
To study the prevalence and clinical features of celiac disease in children to develop new treatment approaches and rehabilitation strategies.
Read the 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
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start1 May 2016
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Celiac Disease in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 3,070 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- I.M. Sechenov First Moscow State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Svetlana Erdes, Ph.D, Study chair, Sechenov First Moscow State Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04272983
- Sponsor's protocol ID
- 16-15-10410
- Status last verified
- Mar 2021
- First submitted
- 13 Feb 2020
- Last updated
- 12 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The local ethics committee does not allow. But upon official request can provide.
Publications
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.
PubMed 28316996Savvateeva 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.
PubMed 30056445Lototskaya 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.
PubMed 31936445
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04272983
- Acronym / sponsor ID
- 16-15-10410
- Conditions
- Celiac Disease in Children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,070 participants (actual)
- Lead sponsor
- I.M. Sechenov First Moscow State Medical UniversityUniversity, hospital or other
- Study start
- 1 May 2016 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 17 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Schoolchildren of the city of Moscow
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Questioning of schoolchildren
Time frame: 2 year
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.
Serological and genetic studies at risk group
Time frame: 3 year
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2021.
- Background: PubMed 28316996Savvateeva 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.
- Background: PubMed 30056445Savvateeva 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.
- Background: PubMed 31936445Lototskaya 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.
- Individual participant dataSharing planned: No. The local ethics committee does not allow. But upon official request can provide.
Related trials for Celiac Disease in Children
Recruiting
GF-NOURISH (Gluten Free Nutrition Optimization Through Ultra-processed Food Reduction and Improved Strategies for Health)
Celiac Disease in Children, Nutrition Disorder, Child
Enrolling by invitation
Assessment of Nutritional Status in Celiac Disease Using Muscle Ultrasound in Pediatric Patients.
Celiac Disease in Children, Nutritional Assessment
Active, not recruiting
Celiac Disease in Childhood-Adulthood Transition
Celiac Disease, Celiac Disease in Children
Enrolling by invitation
Immune Responses to Gluten
Celiac Disease, Malabsorption Syndromes
RecruitingObservational study
Effect of Adherence to a Gluten-Free Diet on Cognitive and Motor Dual-Task Performance in Adolescents Diagnosed With Celiac Disease
Celiac Disease in Children, Celiac Disease in Adolescents
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Svetlana Erdes, Ph.D study chair
Sechenov First Moscow State Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Celiac Disease in Children, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Questioning of schoolchildren (time frame: 2 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04272983, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2021.