Small Bowel Ultrasound and Antibody Levels in Celiac Disease Activity

NCT07453589 | Not Yet Recruiting

• 1 other identifier: US Bowel Patterns & tTG Levels
• Study Type: observational
• Target: 140
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

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

Keywords

Celiac disease; Small bowel ultrasonography; Tissue transglutaminase; Gluten-free diet; Duodenal biopsy

Outcome Measures

Primary Outcomes (1)

• 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).

  Baseline, 6 months, and 12 months.

Study Arms (3)

Newly Diagnosed Patients

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

Diagnostic Test: Small bowel ultrasonography; Diagnostic Test: Serological testing

Patients on Gluten-Free Diet

35 previously diagnosed celiac disease patients on a gluten-free diet requiring follow-up assessment.

Diagnostic Test: Small bowel ultrasonography; Diagnostic Test: Serological testing

Control Group

35 controls with negative serology.

Diagnostic Test: Small bowel ultrasonography; Diagnostic Test: Serological testing

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.

Control Group; Newly Diagnosed Patients; Patients on Gluten-Free Diet

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.

Control Group; Newly Diagnosed Patients; Patients on Gluten-Free Diet

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.
• Patients who provide informed consent (or parental consent for minors).

You may not qualify if:

• 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).
• Patients on immunosuppressive therapy.
• Pregnancy.
• Poor quality ultrasound images due to excessive bowel gas or obesity.
• Refusal to participate in the study.

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Celiac Disease

Interventions

COVID-19 Serological Testing

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

COVID-19 Testing; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Serologic Tests; Immunologic Tests; Investigative Techniques; Immunologic Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer at the Public Health Department, Faculty of Medicine, Assiut University

Study Record Dates

• First Submitted: March 2, 2026
• First Posted: March 6, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: March 6, 2026

Record last verified: 2026-03