Small Bowel Ultrasound and Antibody Levels in Celiac Disease Activity

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age2+
SponsorAssiut University

About this trial

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.

Eligibility criteria

Qualifiers

Patients aged ≥2 years with suspected celiac disease based on clinical symptoms (chronic diarrhea, abdominal distention, weight loss, failure to thrive).

Newly diagnosed celiac disease patients with positive tTG antibodies and/or duodenal biopsy confirmation.

Previously diagnosed celiac disease patients on gluten-free diet requiring follow-up assessment.

Patients with first-degree relatives with celiac disease undergoing screening.

Disqualifiers

Previous small bowel surgery or resection.

Inflammatory bowel disease (Crohn's disease, ulcerative colitis).

Small bowel obstruction from other causes.

IgA deficiency (requires alternative antibody testing).

Trial design

Treatments tested in this trial

  • Small bowel ultrasonography
  • Serological testing

Treatment groups

140 Participants
are divided into 3 treatment groups

Locations

This trial has no locations

Sponsors and collaborators