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
This trial accepts healthy volunteersQualifiers
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 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Small bowel ultrasonography
Diagnostic testA 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 testMeasurement 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.
Treatment groups
140 Participants
are divided into 3 treatment groupsGroup A: Newly Diagnosed Patients2 interventions
Group B: Patients on Gluten-Free Diet2 interventions
Group C: Control Group2 interventions
Trial outcomes
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).
Time frame
Baseline, 6 months, and 12 months.Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: