Clinical trial NCT04019223: Anti-Tissue Transglutaminase IgA Antibodies
Official title: The Diagnostic Performance of Anti-Tissue Transglutaminase IgA Antibodies Serum Level for Detection of Patients With Celiac Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Celiac Disease in Children
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-07-15
Enrollment: 22
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients in this research will be subjected to :

Besides meticulous history and thorough clinical examination, all the cases will be subjected to the following investigations :

* Complete blood count.
* Determination of electrolytes serum levels: Na, K, Mg, Ca and Ph.
* Liver function tests.
* Determination of anti-tissue transglutaminase IgA antibodies serum level.
* Intestinal biopsy for histopathology study the jejunal histopathological
* examinations will be done at the Histopathology Laboratory.
* The features consistent with CD included: hyperplasia
* of crypts, atrophy of villous, and increase of intraepithelial
* lymphocytes.

Brief summary: Celiac disease is the most common genetically related food intolerance, worldwide. It is an immune mediated intolerance to gluten (from wheat, barley, or rye) in genetically susceptible individuals .The disease primarily affects the small intestine, where it progressively leads to flattening of the small intestinal mucosa .

Detailed description: Within this definition, patients can further be defined as having silent, potential, or latent celiac disease. The term silent celiac disease refers to patients fulfilling the definition above, but presenting no symptoms. Typically, such diagnoses are made by screening asymptomatic individuals, who are at increased risk for celiac disease. The term potential celiac disease describes patients who have specific serum autoantibodies and may or may not have symptoms consistent with celiac disease, but lack evidence of the autoimmune damage to the intestinal mucosa. A final category of celiac patients is represented by the so-called latent celiac disease: individuals with normal mucosal morphology (like the potential) but known to have had a gluten-dependent enteropathy at some point in their life .

Malabsorption results from injury to the small intestine with loss of absorptive surface area, reduction of digestive enzymes, and consequential impaired absorption of micronutrients such as fat-soluble vitamins, iron and potentially B12 and folic acid. In addition, the inflammation exacerbates symptoms of malabsorption by causing net secretion of fluid that can result in diarrhea. The failure of absorption of adequate calories leads to weight loss, and the malabsorption results in abdominal pain and bloating .

A positive family history is a risk factor for celiac disease. The frequency of celiac disease is higher among first- and second-degree relatives of persons with celiac disease, although prevalence estimates range from 5 to 20 percent . Frequency of celiac disease is also higher among persons with other autoimmune diseases, such as type 1 diabetes mellitus, inflammatory luminal gastrointestinal disorders, Down syndrome, Turner's syndrome, IgA deficiency, and IgA nephropathy .

Gastrointestinal and extra-intestinal manifestations of celiac disease include diarrhea, abdominal pain, abdominal distention, anorexia, vomiting, constipation, failure to thrive, chronic fatigue, anemia, osteoporosis, aphthous stomatitis, elevated liver enzymes, joint/muscle pain, epilepsy, and peripheral neuropathy .

Clinical practice guidelines recommend to starting with the serum anti-tissue transglutaminase IgA antibodies (anti-tTG IgA) test as a diagnostic testing for celiac disease. The tTG IgA test is the standard method of testing for celiac disease . Clinical practice in guidelines the United States and Europe recommend intestinal biopsy to confirm the diagnosis of celiac disease (e.g., based on presence of villous atrophy hyperplasia of crypts, and increase of intraepithelial lymphocytes) and to distinguish celiac disease from other disorders affecting the small intestine. Intestinal biopsy may also be performed if clinical suspicion for celiac disease is high but serologic tests are negative . It has been suggested that a combination of serologic tests could be used to establish celiac disease diagnosis as an alternative to biopsy, but it is unclear how frequently celiac disease is diagnosed in the absence of biopsy in clinical practice.

Eligibility criteria: Inclusion Criteria:

* • patients with symptoms suggestive of celiac disease

Exclusion Criteria:

•chronic active gastrointestinal disease, i.e., irritable bowel syndrome inflammatory bowel disease .

Primary outcomes:
measure: measure of Anti- tissue will be performed to calculate the post-test probability of celiac disease.
timeFrame: within 24 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Richey R, Howdle P, Shaw E, Stokes T; Guideline Development Group. Recognition and assessment of coeliac disease in children and adults: summary of NICE guidance. BMJ. 2009 May 27;338:b1684. doi: 10.1136/bmj.b1684. No abstract available.
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