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临床试验/NCT07453589
NCT07453589尚未招募不适用

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

Assiut University0 个研究点目标入组 140 人开始时间: 2026年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
140
主要终点
Small Bowel Ultrasound Severity Score

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
2 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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).

排除标准

  • 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.

研究组 & 干预措施

Newly Diagnosed Patients

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

干预措施: Small bowel ultrasonography (Diagnostic Test)

Newly Diagnosed Patients

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

干预措施: Serological testing (Diagnostic Test)

Patients on Gluten-Free Diet

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

干预措施: Small bowel ultrasonography (Diagnostic Test)

Patients on Gluten-Free Diet

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

干预措施: Serological testing (Diagnostic Test)

Control Group

35 controls with negative serology.

干预措施: Small bowel ultrasonography (Diagnostic Test)

Control Group

35 controls with negative serology.

干预措施: Serological testing (Diagnostic Test)

结局指标

主要结局

Small Bowel Ultrasound Severity Score

时间窗: 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).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mireille Maged Emile Hanna

Assistant Lecturer at the Public Health Department, Faculty of Medicine, Assiut University

Assiut University

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