Small Bowel Ultrasound and Antibody Levels in Celiac Disease Activity

Sponsor
Assiut University
Study ID
NCT07453589
Status
Not Yet Recruiting

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Conditions

  • Celiac Disease
  • Small Bowel Ultrasonography
  • Tissue Transglutaminase Antibody
  • Ultrasound

Eligibility Criteria

Sex
ALL
Age
2 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Small bowel ultrasonography — DIAGNOSTIC_TEST
    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.
  • Serological testing — DIAGNOSTIC_TEST
    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.

Study Details

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.

Key Dates

Start date
Apr 30, 2026
Status verified
Mar 2026
Primary completion
Apr 30, 2027
Completion
May 31, 2027

Study Design

Enrollment
140 participants (estimated)

Arms

  • Arm: Newly Diagnosed Patients
    70 newly diagnosed celiac disease patients with positive tTG antibodies and/or duodenal biopsy confirmation.
  • Arm: Patients on Gluten-Free Diet
    35 previously diagnosed celiac disease patients on a gluten-free diet requiring follow-up assessment.
  • Arm: Control Group
    35 controls with negative serology.

Primary Outcome Measure

Small Bowel Ultrasound Severity Score [ Time Frame: Baseline, 6 months, and 12 months. ]

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