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临床试验/NCT04351828
NCT04351828已完成不适用

The Investigation of Nutritional Status, Intestinal Permeability and Quality of Life in People With Celiac Disease

Marmara University1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2018年11月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
44
试验地点
1
主要终点
Serum zonulin levels of people with celiac disease

研究概览

简要总结

Celiac disease is defined as an autoimmune enteropathy with malabsorption of gluten protein. In recent studies, it has been stated that in individuals diagnosed with celiac disease, intestinal epithelial barrier integrity is impaired. Increased zonulin concentration in blood is considered as an indicator of increased intestinal permeability.

Gluten-free diet is the only treatment of celiac disease. Adherence to gluten free diet provides decreasing of intestinal permeability however gluten free diet has different aspects on nutritional status and health related quality of life in people with celiac disease.

The aim of this study is to determine nutritional status, intestinal permeability and quality of life in people with celiac disease. In the study,it primarily hypothesized that celiac patients noncompliant to gluten-free diet may have increased circulating levels of zonulin and increased intestinal permeability compared to celiac patients compliant to gluten-free diet.

详细描述

Celiac disease is defined as an autoimmune enteropathy that progresses with malabsorption of gluten protein found in wheat, barley, rye and small intestinal mucosal inflammation in individuals with genetic predisposition. Disruption of intestinal barrier integrity play role in the pathogenesis of celiac disease. Zonulin levels increase in the disruption of intestinal permeability in celiac patients.

At the present, the only treatment of celiac disease is life-long gluten-free diet and it requires strict gluten elimination . With compliance to gluten-free diet, thickening of intestinal mucosal layer, decreasing of villi atrophy and decreasing of transcellular infiltration are observed. In other studies, it was stated that adherence to gluten-free diet can repair intestinal permeability and decrease zonulin levels.

While compliance to gluten-free diet is a key point to prevent progression of the disease, nutritional quality of the gluten-free diet affects nutritional status of patients. Moreover,restricted diets in terms of energy or various nutrients affect health-related quality of life. In studies examining all aspects of celiac disease, it has been stated that health-related factors reduce the quality of life in celiac patients.

In conclusion, this study aims to investigate the presence of intestinal permeability with serum zonulin levels in celiac patients, to evaluate nutritional status of patients with anthropometric measurements and food consumption records, and to determine quality of life of patients with validated celiac disease questionnaire. This study in Turkey, is also first study that investigate all these three factors.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 64 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • To be between the ages of 18-64,
  • To be literate,
  • To have positive serological anti tissue transglutaminase immunoglobulin A antibodies value,
  • To have a small intestinal biopsy proven celiac disease diagnosis at the time of gastrointestinal endoscopy
  • To be volunteer by signing the informed consent form.

排除标准

  • To have another autoimmune disease such as type 1 diabetes, psoriasis, hashimoto's thyroiditis, rheumatoid arthritis, systemic lupus erythematosus,
  • To be in pregnancy or lactation period,
  • Taking probiotic/ prebiotics supplements in the last 2 months,
  • Taking antibiotics or non-steroidal antiinflammatory drugs in the last 1 week.

结局指标

主要结局

Serum zonulin levels of people with celiac disease

时间窗: 1 day

Zonulin accepted as an indicator of increased intestinal barrier permeability in previous studies . In this research protocol, zonulin kits were used and zonulin levels were analyzed by sandwich enzyme linked immunosorbent assay (ELISA) method in both celiac patients compliant to gluten free diet group and noncompliant to gluten free diet group.

次要结局

  • Quality of life of people with celiac disease(1 day)
  • Dietary intake levels of people with celiac disease(1 day)
  • Body weight, fat and muscle mass measurements of people with celiac disease(1 day)
  • Body height, waist and hip circumference measurements of people with celiac disease(1 day)
  • Calculation of waist circumference to hip circumference ratio of people with celiac disease(1 day)

研究者

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

Yeşim Öztekin

Principal Investigator

Marmara University

研究点 (1)

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