- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06164548
Celiac Disease Among Egyptian Children With Unexplained Short Stature
Study Overview
Status
Conditions
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Esraa Atef Shehataa
- Phone Number: 01017179841
- Email: esoo3atef@gmail.com
Study Contact Backup
- Name: Shereen Mansour Galal, As.Professor
- Phone Number: 01003162310
- Email: shereen80@aun.edu.eg
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
(1) 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.
Exclusion Criteria:
Short children with demonstrable cause such as:
(1) 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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Celiac Disease Among Egyptian Children With Unexplained Short Stature
Time Frame: Baseline
|
Detect prevalence of celiac disease in children presented with unexplained short stature
|
Baseline
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Ahmed 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.
- Itzlinger 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.
- 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.
- Ertekin 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.
- Jericho 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- celiac disease
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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