Celiac DiseaseNCT06164548
Celiac Disease Among Egyptian Children With Unexplained Short Stature
An observational study of Celiac Disease, run by Assiut University.
Trial summary
Detect the prevalence of celiac disease in children with unexplained short stature attended at Assiut University Children Hospital. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Celiac Disease
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2024to 31 Mar 2025
- 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 2 to 18 years
- All sexes
- Child, Adult
Study population: Children aged between 2-18 years with undetectable causes of short stature
Who may be able to join
- Children aged between 2-18 years with undetectable causes of short stature whose height was < -2 SDfor the ageandsexaccording to Z score growth references for Egyptianchildrenand adolescent growth reference and Control DiseaseCenter(CDC) charts. (2) Short children not previously screened for Celiac disease.
Who cannot join
- Short children with demonstrable cause such as:
- Familial and constitutional short stature. (2) Chronic illness. (3) Disproportionate short stature. (4) Short stature of endocrinal origin (eg, growth hormone deficiency). (5) Turner syndrome. (6) Short stature with significant congenital anomalies. (7) Patients on gluten free diet.
Trial locations and contacts
No sites are listed yet.
About this study
Detect the prevalence of celiac disease in children with unexplained short stature attended at Assiut University Children Hospital.
Read the detailed description
Short stature is a term applied to a child whose height is 2 standard deviations or more below the mean for children of that chronological age and sex , and ideally of the same racial - ethnic group.This corresponds to a height below 3rd centile .Short stature can be the result of normal growth variants e.g. familial or constitutional which are the most common causes in children below one or two years ,or it can be the result of chronic systemic disorders, endocrine disorders, genetic, chromosomal disorders, and skeletal dysplasia. Chronic malnutrition and chemotherapy can also result in short stature -Around 3-2.5% of the children worldwide are short.
The Egyptian Demographic and Health Survey of 2008 (EDHS 2008) revealed that the prevalence of stunting among children under 5 was 2%28.9, while that of the EDHS 2014 was found to be 21%
- The goal of the evaluation of a child with short stature is to identify the subset of children with pathologic causes (such as Turner syndrome, inflammatory bowel disease , Celiac disease or other underlying systemic disease, or growth hormone deficiency). The evaluation also assesses the severity of the short stature and likely growth trajectory, to facilitate decisions about intervention, if appropriate.
- Celiac disease , also known as gluten enteropathy, is a chronic autoimmune condition, in genetically susceptible persons, perpetuated by the ingested gluten from cereals, wheat and barley,causes damage to the intestinal mucosa by an autoimmune reaction leading to villous atrophy. Villous atrophy then leads to multiple micro and macronutrient deficiencies.
Worldwide, its prevalence is about 1% ,affecting females twice more than males.
- Classic symptoms include gastrointestinal problems such as chronic diarrhea, abdominal distension, malabsorption, loss of appetite, and among children failure to grow normally. This often begins between six months and two years of age. Non-classic (extra intestinal) symptoms (eg, short stature, delayed puberty, epilepsy, peripheral neuritis and iron defiency anemia) are the most common, especially in people older than two years.
- Malabsorption is the typical presentation in early childhood, whereas older children with celiac disease can present with extra-intestinal symptoms including short stature and delay in pubertal development.
Short stature is the most commonly encountered extra- intestinal manifestation of CD in children, being found in roughly one-third of all new pediatric celiac diagnoses.
- Singh et al., showed an 11% prevalence of celiac disease among children presenting with short stature at a tertiary care hospital. Results from two European studies on short stature show celiac disease prevalence at 2:180 and 0:149 respectively. In short stature children without gastrointestinal signs, the prevalence of celiac disease raised up to 8-2%. By excluding endocrine causes of short stature, celiac disease prevalence will raise to even 59%
- In Egypt celiac disease is a frequent disorder among children, both in the general population (0.53%) and in at-risk groups (6.4%) The standard method of diagnosing celiac disease in symptomatic persons older than 2 years is the tissue transglutaminase (tTG) IgA test, followed by intestinal biopsy for histologic confirmation -The only known effective treatment is a strict lifelong gluten- free diet, which leads to recovery of the intestinal mucosa, improves symptoms, and reduced risk of developing complications in most people. If untreated it may result in cancers such as intestinal lymphoma and a slight increased risk of early death Vitamin and mineral supplements ,medications to control intestinal inflammation as steroids and Other drugs, such as azathioprine (Azasan, Imuran) or budesonide (Entocort EC, Uceris), might be used , in addition to control of complications like peripheral neuropathy, mouth ulcers and ataxia.
- Conditions
- Celiac Disease
- Medical subject headings
- Celiac Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Celiac Disease Among Egyptian Children With Unexplained Short Stature
Detect prevalence of celiac disease in children presented with unexplained short stature
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2023
- Study start15 Jan 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Celiac DiseaseStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esraa Atef Shehataa, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06164548
- Sponsor's protocol ID
- celiac disease
- Status last verified
- Dec 2023
- First submitted
- 2 Dec 2023
- Last updated
- 11 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Voss LD, Mulligan J, Betts PR, Wilkin TJ. Poor growth in school entrants as an index of organic disease: the Wessex growth study. BMJ. 1992 Dec 5;305(6866):1400-2. doi: 10.1136/bmj.305.6866.1400.
PubMed 1486305Ertekin V, Selimoglu MA, Kardas F, Aktas E. Prevalence of celiac disease in Turkish children. J Clin Gastroenterol. 2005 Sep;39(8):689-91. doi: 10.1097/01.mcg.0000174026.26838.56.
PubMed 16082278Ahmed ML, Allen AD, Sharma A, Macfarlane JA, Dunger DB. Evaluation of a district growth screening programme: the Oxford Growth Study. Arch Dis Child. 1993 Sep;69(3):361-5. doi: 10.1136/adc.69.3.361.
PubMed 7692826Itzlinger A, Branchi F, Elli L, Schumann M. Gluten-Free Diet in Celiac Disease-Forever and for All? Nutrients. 2018 Nov 18;10(11):1796. doi: 10.3390/nu10111796.
PubMed 30453686Jericho H, Sansotta N, Guandalini S. Extraintestinal Manifestations of Celiac Disease: Effectiveness of the Gluten-Free Diet. J Pediatr Gastroenterol Nutr. 2017 Jul;65(1):75-79. doi: 10.1097/MPG.0000000000001420.
PubMed 28644353
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Celiac Disease Among Egyptian Children With Unexplained Short Stature
- ClinicalTrials.gov ID
- NCT06164548
- Acronym / sponsor ID
- celiac disease
- Conditions
- Celiac Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Jan 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 11 Dec 2023 (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.
Detect the prevalence of celiac disease in children with unexplained short stature attended at Assiut University Children Hospital.
Detailed description
Short stature is a term applied to a child whose height is 2 standard deviations or more below the mean for children of that chronological age and sex , and ideally of the same racial - ethnic group.This corresponds to a height below 3rd centile .Short stature can be the result of normal growth variants e.g. familial or constitutional which are the most common causes in children below one or two years ,or it can be the result of chronic systemic disorders, endocrine disorders, genetic, chromosomal disorders, and skeletal dysplasia. Chronic malnutrition and chemotherapy can also result in short stature -Around 3-2.5% of the children worldwide are short.
The Egyptian Demographic and Health Survey of 2008 (EDHS 2008) revealed that the prevalence of stunting among children under 5 was 2%28.9, while that of the EDHS 2014 was found to be 21%
- The goal of the evaluation of a child with short stature is to identify the subset of children with pathologic causes (such as Turner syndrome, inflammatory bowel disease , Celiac disease or other underlying systemic disease, or growth hormone deficiency). The evaluation also assesses the severity of the short stature and likely growth trajectory, to facilitate decisions about intervention, if appropriate.
- Celiac disease , also known as gluten enteropathy, is a chronic autoimmune condition, in genetically susceptible persons, perpetuated by the ingested gluten from cereals, wheat and barley,causes damage to the intestinal mucosa by an autoimmune reaction leading to villous atrophy. Villous atrophy then leads to multiple micro and macronutrient deficiencies.
Worldwide, its prevalence is about 1% ,affecting females twice more than males.
- Classic symptoms include gastrointestinal problems such as chronic diarrhea, abdominal distension, malabsorption, loss of appetite, and among children failure to grow normally. This often begins between six months and two years of age. Non-classic (extra intestinal) symptoms (eg, short stature, delayed puberty, epilepsy, peripheral neuritis and iron defiency anemia) are the most common, especially in people older than two years.
- Malabsorption is the typical presentation in early childhood, whereas older children with celiac disease can present with extra-intestinal symptoms including short stature and delay in pubertal development.
Short stature is the most commonly encountered extra- intestinal manifestation of CD in children, being found in roughly one-third of all new pediatric celiac diagnoses.
- Singh et al., showed an 11% prevalence of celiac disease among children presenting with short stature at a tertiary care hospital. Results from two European studies on short stature show celiac disease prevalence at 2:180 and 0:149 respectively. In short stature children without gastrointestinal signs, the prevalence of celiac disease raised up to 8-2%. By excluding endocrine causes of short stature, celiac disease prevalence will raise to even 59%
- In Egypt celiac disease is a frequent disorder among children, both in the general population (0.53%) and in at-risk groups (6.4%) The standard method of diagnosing celiac disease in symptomatic persons older than 2 years is the tissue transglutaminase (tTG) IgA test, followed by intestinal biopsy for histologic confirmation -The only known effective treatment is a strict lifelong gluten- free diet, which leads to recovery of the intestinal mucosa, improves symptoms, and reduced risk of developing complications in most people. If untreated it may result in cancers such as intestinal lymphoma and a slight increased risk of early death Vitamin and mineral supplements ,medications to control intestinal inflammation as steroids and Other drugs, such as azathioprine (Azasan, Imuran) or budesonide (Entocort EC, Uceris), might be used , in addition to control of complications like peripheral neuropathy, mouth ulcers and ataxia.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Children aged between 2-18 years with undetectable causes of short stature
Key inclusion criteria (1 listed)
- Children aged between 2-18 years with undetectable causes of short stature whose height was < -2 SDfor the ageandsexaccording to Z score growth references for Egyptianchildrenand adolescent growth reference and Control DiseaseCenter(CDC) charts. (2) Short children not previously screened for Celiac disease.
Key exclusion criteria (2 listed)
- Familial and constitutional short stature. (2) Chronic illness. (3) Disproportionate short stature. (4) Short stature of endocrinal origin (eg, growth hormone deficiency). (5) Turner syndrome. (6) Short stature with significant congenital anomalies. (7) Patients on gluten free diet.
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
Celiac Disease Among Egyptian Children With Unexplained Short Stature
Time frame: Baseline
Detect prevalence of celiac disease in children presented with unexplained short stature
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2023.
- Background: PubMed 1486305Voss LD, Mulligan J, Betts PR, Wilkin TJ. Poor growth in school entrants as an index of organic disease: the Wessex growth study. BMJ. 1992 Dec 5;305(6866):1400-2. doi: 10.1136/bmj.305.6866.1400.
- Background: PubMed 16082278Ertekin V, Selimoglu MA, Kardas F, Aktas E. Prevalence of celiac disease in Turkish children. J Clin Gastroenterol. 2005 Sep;39(8):689-91. doi: 10.1097/01.mcg.0000174026.26838.56.
- Background: PubMed 7692826Ahmed ML, Allen AD, Sharma A, Macfarlane JA, Dunger DB. Evaluation of a district growth screening programme: the Oxford Growth Study. Arch Dis Child. 1993 Sep;69(3):361-5. doi: 10.1136/adc.69.3.361.
- Background: PubMed 30453686Itzlinger A, Branchi F, Elli L, Schumann M. Gluten-Free Diet in Celiac Disease-Forever and for All? Nutrients. 2018 Nov 18;10(11):1796. doi: 10.3390/nu10111796.
- Background: PubMed 28644353Jericho H, Sansotta N, Guandalini S. Extraintestinal Manifestations of Celiac Disease: Effectiveness of the Gluten-Free Diet. J Pediatr Gastroenterol Nutr. 2017 Jul;65(1):75-79. doi: 10.1097/MPG.0000000000001420.
Related trials for Celiac Disease
Active, not recruitingEarly Phase 1
VTP-1000 in Adults With Celiac Disease
Celiac Disease
RecruitingObservational study
Impact of Mediterranean Diet and Processed Food Consumption on Gastrointestinal Symptoms in Coeliac Patients on a Gluten-Free Diet
Celiac Disease, Gluten-free Diet
Recruiting
GF-NOURISH (Gluten Free Nutrition Optimization Through Ultra-processed Food Reduction and Improved Strategies for Health)
Celiac Disease in Children, Nutrition Disorder, Child
RecruitingObservational study
Celiac Disease Genomic Environmental Microbiome and Metabolomic Study
Celiac Disease
RecruitingObservational study
Pathogenic Study of Adult Immune Enteropathies
Celiac Disease, Autoimmune Enteropathy
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Celiac Disease, run by Assiut University.
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 1 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: status not confirmed, as of the sponsor's last update on 11 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Esraa Atef Shehataa (01017179841, esoo3atef@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Celiac Disease Among Egyptian Children With Unexplained Short Stature (time frame: Baseline). 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 NCT06164548, which also lists 5 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 11 Dec 2023.