An observational study in Celiac Disease, Ultrasound and Tissue Transglutaminase Antibody, sponsored by Assiut University. Not yet recruiting. Open to participants aged 2 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-06.
Sponsored by Assiut University · Observational
This observational study aims to evaluate the relationship between small bowel ultrasound findings and tissue transglutaminase (tTG) antibody blood levels in assessing celiac disease activity. The traditional gold standard for diagnosing and monitoring celiac disease involves an invasive duodenal biopsy. Researchers want to determine if combining a painless, non-invasive small bowel ultrasound with tTG antibody blood tests can accurately predict disease severity and monitor a patient's response to a gluten-free diet.
The study will enroll 140 participants aged 2 years and older, including newly diagnosed patients, patients currently on a gluten-free diet, and a control group. All participants will undergo a clinical assessment, blood tests for tTG antibodies, and a high-resolution small bowel ultrasound. Newly diagnosed patients will also undergo an upper gastrointestinal endoscopy and biopsy to confirm their diagnosis. Researchers will score the ultrasound severity based on factors like bowel wall thickness and compare it to the antibody levels. A cohort of patients will be monitored over time with serial assessments at baseline, 6 months, and 12 months.
Celiac disease is an immune-mediated systemic disorder triggered by gluten ingestion in genetically susceptible individuals. While the gold standard for diagnosis is a duodenal biopsy demonstrating villous atrophy, this procedure is invasive. Tissue transglutaminase (tTG) antibody testing, particularly IgA anti-tTG, has become the preferred serological test. Small bowel ultrasonography (SBUS) has emerged as a non-invasive imaging modality capable of detecting structural changes such as increased bowel wall thickness, dilated fluid-filled bowel loops, and enlarged mesenteric lymph nodes. Studies have shown correlations between ultrasound findings and histological severity. However, limited data exists on the correlation between quantitative tTG levels and specific ultrasound patterns. This study aims to evaluate this relationship to assess celiac disease activity and evaluate the diagnostic accuracy of combined non-invasive parameters.
This is a prospective cross-sectional and longitudinal observational study conducted at AL-Rajhi University Hospital, Assiut University, Egypt. Patients will undergo comprehensive clinical assessments, including medical history, physical examination, and dietary history evaluation. Laboratory investigations will include measuring IgA tissue transglutaminase antibody (tTG-IgA) by ELISA, total serum IgA to exclude deficiency, and routine tests such as complete blood count, iron studies, and liver function tests. All participants will undergo small bowel ultrasonography after fasting for 4-6 hours. The ultrasound will systematically scan all small bowel segments, assessing parameters like bowel wall thickness, layering, lumen diameter, intraluminal fluid content, and peristaltic activity. A severity score ranging from 0 to 11 will be calculated based on these parameters. Newly diagnosed patients will additionally undergo an upper gastrointestinal endoscopy with a minimum of 4-6 duodenal biopsies, graded according to the Marsh-Oberhuber classification. The treatment monitoring cohort will undergo serial assessments at baseline, 6 months, and 12 months.
333 studies on the registry are indexed under Celiac Disease; 78 are open to participants now.
This study's planned enrollment of 140 is below the median of 160 across 126 observational studies indexed under Celiac Disease.
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The study population consists of individuals aged 2 years and older recruited from the Department of Gastroenterology and Hepatology at AL-Rajhi University Hospital, Egypt. This includes patients with suspected or newly diagnosed celiac disease, previously diagnosed patients being monitored on a gluten-free diet, individuals undergoing screening due to a family history of celiac disease, and a control group of individuals with negative serology.
Exclusion Criteria:
70 newly diagnosed celiac disease patients with positive tTG antibodies and/or duodenal biopsy confirmation.
Diagnostic Test: Small bowel ultrasonography · Diagnostic Test: Serological testing
35 previously diagnosed celiac disease patients on a gluten-free diet requiring follow-up assessment.
Diagnostic Test: Small bowel ultrasonography · Diagnostic Test: Serological testing
35 controls with negative serology.
Diagnostic Test: Small bowel ultrasonography · Diagnostic Test: Serological testing
A systematic scanning of all small bowel segments from the duodenum to the terminal ileum. The examination is performed using a high-resolution ultrasound machine with 5-12 MHz linear and 3.5-5 MHz convex transducers.
Measurement of IgA tissue transglutaminase antibody (tTG-IgA) by ELISA, total serum IgA level to exclude IgA deficiency, and IgG tissue transglutaminase antibody (tTG-IgG) for IgA-deficient patients.
Small Bowel Ultrasound Severity Score
Disease activity will be assessed using a small bowel ultrasound scoring system to correlate with tissue transglutaminase (tTG) antibody levels. The score evaluates five ultrasonographic parameters: wall thickness (0-3 points), dilatation (0-2 points), fluid content (0-2 points), lymphadenopathy (0-2 points), and peristalsis (0-2 points). The total score ranges from 0 to 11, where higher scores indicate greater disease severity (0-3: mild, 4-7: moderate, 8-11: severe).
Time frame: Baseline, 6 months, and 12 months.
No study locations are listed for this record.
This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Assiut University