- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06783673
Celiac Disease in Children
Clinicopathological, Endoscopic and Serological Patterns of Celiac Disease in Children at Sohag University Hospital
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Celiac disease (CD), or gluten-sensitive enteropathy, is an immune-mediated enteropathy triggered by the ingestion of gluten-containing cereals (wheat, barley, and rye) in genetically susceptible individuals. Undiagnosed CD may cause intestinal (e.g. chronic diarrhea, failure to thrive) and/or extra intestinal (e.g. anemia, osteoporosis, dermatitis herpetiformis) manifestations.
The etiology of CD is multifactorial, with both genetic and environmental factors involved in disease development. Susceptibility to CD is primarily associated with the human leukocyte antigen HLA-DQ2 allele. The heterodimer DQA1*0501 and DQB1*0201 is detected in up to 95% of persons with celiac disease, with the remaining 5% expressing HLA-DQ8 (DQA1*0301, DQB1*0302). The frequency of these alleles in the general populations in Western countries is 20% to 30%. Therefore, an individual not carrying DQ2 or DQ8 alleles is extremely unlikely to develop CD.
Celiac disease is associated with a host of autoimmune diseases such as type 1 diabetes mellitus, autoimmune thyroid disease, Addison disease, autoimmune hepatitis, primary biliary cirrhosis, primary sclerosing cholangitis, and immunoglobulin (Ig) A deficiency. There is also an increased prevalence of CD in patients with genetic disorders such as Down syndrome and Turner syndrome.
Serologic testing is recommended as the first step in pursuing a diagnosis of CD, however, small-bowel mucosal biopsy is currently considered the gold standard for diagnosing CD. All serologic tests and small-bowel biopsies need to be performed while the patient is on a gluten-containing diet.
The characteristics of small intestine biopsies from CD include partial or complete villous atrophy, crypt hyperplasia, and intraepithelial lymphocyte infiltration.
According to the modified Marsh classification, the intestinal damage is divided into four stages. Stage 0 intestinal damage is characterized by the lesion invasion in the mucous layer, the increased number of intraepithelial lymphocytes and the presence of lymphocytes in the lamina propria, whereas Stage 1 damage features microscopic enteritis with an increase of intraepithelial lymphocytes. A feature of Stage 2 intestinal damage is crypt hyperplasia along with villous atrophy while Stage 3 is characterized by a complete atrophy of the intestinal villi.
Treatment of CD includes lifelong gluten-free diet. The clinical and histological benefits of a gluten-free diet (GFD) in the management of CD are well recognized showing that the degree of histological recovery is dependent upon how strict the patient adheres to the diet.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Sohag, Egypt, 82524
- Sohag University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Children less than 18 years.
- Both sexes.
- Children suffering from manifestations of celiac disease.
- Children previously diagnosed with celiac disease.
Exclusion Criteria:
- cases more than 18 years.
- Children diagnosed with other causes of malabsorption
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
patterns of celiac disease in children
clinicopathological, endoscopic and serological patterns of celiac disease in children
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upper GIT endoscopy of suspected cases and multiple biopsies will be taken for histopathological examination
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of participants with Clinicopathological, endoscopic and serological patterns of Celiac disease
Time Frame: 1 Year
|
clinical patterns of celiac disease include intestinal and extraintestinal manifestations. serological patterns include total IgA level, tissue transglutaminase IgA & IgG levels and endomesial IgA & IgG levels. Endoscopic patterns include patchy or generalized atrophy and scalloping of duodenal mucosa. Pathological patterns include features of mucosal atrophy and modified Marsh classification. |
1 Year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Soh-Med--24-11-10MS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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