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NCT07453589

Small Bowel Ultrasound and Antibody Levels in Celiac Disease Activity

Sponsor: Assiut University

View on ClinicalTrials.gov

Summary

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.

Official title: Ultrasound Small Bowel Patterns and Tissue Transglutaminase Antibody Levels in Celiac Disease Activity

Key Details

Gender

All

Age Range

2 Years - Any

Study Type

OBSERVATIONAL

Enrollment

140

Start Date

2026-04

Completion Date

2027-05

Last Updated

2026-03-06

Healthy Volunteers

Yes

Interventions

DIAGNOSTIC_TEST

Small bowel ultrasonography

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.

DIAGNOSTIC_TEST

Serological testing

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.