Small Bowel Ultrasound and Antibody Levels in Celiac Disease Activity

March 2, 2026 updated by: Mireille Maged Emile Hanna, Assiut University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

140

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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.

Description

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Newly Diagnosed Patients
70 newly diagnosed celiac disease patients with positive tTG antibodies and/or duodenal biopsy confirmation.
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.
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
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.
Control Group
35 controls with negative serology.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Small Bowel Ultrasound Severity Score
Time Frame: Baseline, 6 months, and 12 months.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

March 2, 2026

First Submitted That Met QC Criteria

March 2, 2026

First Posted (Actual)

March 6, 2026

Study Record Updates

Last Update Posted (Actual)

March 6, 2026

Last Update Submitted That Met QC Criteria

March 2, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • US Bowel Patterns & tTG Levels

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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