Celiac Disease in ChildrenNCT06783673
Celiac Disease in Children
An observational study of Celiac Disease in Children, run by Sohag University at 1 site in Egypt.
Trial summary
The aim is to study the clinical, serological, endoscopic and histopathological characteristics and treatment outcome of children diagnosed with celiac disease in Sohag University Hospital Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Celiac Disease in Children
- What is being tested?
- Upper GIT endoscopy
- Type of treatment
- Surgery or procedure
- How many people
- 66 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Aug 2024to 30 Mar 2025
- How long will I take part?
- 6 Months
- 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 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The study will include children who will be admitted to the department of pediatrics at Sohag University Hospital during the study period and which will be fulfilling the following eligibility criteria in addition to all children previously diagnosed with celiac disease in the last 1 years.
Who may be able to join
- Children less than 18 years.
- Both sexes.
- Children suffering from manifestations of celiac disease.
- Children previously diagnosed with celiac disease.
Who cannot join
- cases more than 18 years.
- Children diagnosed with other causes of malabsorption
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinicopathological, Endoscopic and Serological Patterns of Celiac Disease in Children at Sohag University Hospital
The aim is to study the clinical, serological, endoscopic and histopathological characteristics and treatment outcome of children diagnosed with celiac disease in Sohag University Hospital
Read the 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.
- Conditions
- Celiac Disease in Children
- Being tested
- Upper GIT endoscopy
- Keywords
- clinicopathological, endoscopic and serological patterns of celiac disease in children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Upper GIT endoscopyProcedure or surgery
Also called Upper endoscopy
upper GIT endoscopy of suspected cases and multiple biopsies will be taken for histopathological examination
| Study group | Role | What they receive |
|---|---|---|
| patterns of celiac disease in children | clinicopathological, endoscopic and serological patterns of celiac disease in children Receives: Procedure: Upper GIT endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Clinicopathological, endoscopic and serological patterns of Celiac disease
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.
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2025
- Study start25 Aug 2024
- Primary completion3 Mar 2025
- Study completion30 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Case-control
- Time perspective
- Other
- Enrolment
- 66 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Ali Abdelraheem, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06783673
- Sponsor's protocol ID
- Soh-Med--24-11-10MS
- Status last verified
- Apr 2025
- First submitted
- 30 Dec 2024
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinicopathological, Endoscopic and Serological Patterns of Celiac Disease in Children at Sohag University Hospital
- ClinicalTrials.gov ID
- NCT06783673
- Acronym / sponsor ID
- Soh-Med--24-11-10MS
- Conditions
- Celiac Disease in Children
- Keywords
- clinicopathological, endoscopic and serological patterns of celiac disease in children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 25 Aug 2024 (actual)
- Primary completion
- 3 Mar 2025 (actual)
- Study completion
- 30 Mar 2025 (actual)
- First posted
- 20 Jan 2025 (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.
The aim is to study the clinical, serological, endoscopic and histopathological characteristics and treatment outcome of children diagnosed with celiac disease in Sohag University Hospital
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 design
- Observational model
- Case-control
- Time perspective
- Other
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patterns of celiac disease in children | – | Procedure: Upper GIT endoscopyclinicopathological, endoscopic and serological patterns of celiac disease in children |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The study will include children who will be admitted to the department of pediatrics at Sohag University Hospital during the study period and which will be fulfilling the following eligibility criteria in addition to all children previously diagnosed with celiac disease in the last 1 years.
Key inclusion criteria (4 listed)
- Children less than 18 years.
- Both sexes.
- Children suffering from manifestations of celiac disease.
- Children previously diagnosed with celiac disease.
Key exclusion criteria (2 listed)
- cases more than 18 years.
- Children diagnosed with other causes of malabsorption
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Upper GIT endoscopyAlso: Upper endoscopyupper GIT endoscopy of suspected cases and multiple biopsies will be taken for histopathological examination | Procedure or surgery | patterns of celiac disease in children |
Primary outcome
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.
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 9 Apr 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Celiac Disease in Children
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Assessment of Nutritional Status in Celiac Disease Using Muscle Ultrasound in Pediatric Patients.
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Celiac Disease in Childhood-Adulthood Transition
Celiac Disease, 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
Immune Responses to Gluten
Celiac Disease, Malabsorption Syndromes
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Effect of Adherence to a Gluten-Free Diet on Cognitive and Motor Dual-Task Performance in Adolescents Diagnosed With Celiac Disease
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Sohag University at 1 site in Egypt.
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 4 inclusion and 2 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 9 Apr 2025. 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 Egypt. 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?
Number of participants with Clinicopathological, endoscopic and serological patterns of Celiac disease (time frame: 1 Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Apr 2025.