Celiac Disease Among Egyptian Children With Unexplained Short Stature

Study Purpose

Detect the prevalence of celiac disease in children with unexplained short stature attended at Assiut University Children Hospital.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Unknown
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 2 Years - 18 Years
Gender All
More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06164548
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Assiut University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Not yet recruiting
Countries
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Celiac Disease
Additional Details

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.

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Esraa Atef Shehataa

esoo3atef@gmail.com

01017179841

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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