Intestinal Permeability, Nutritional Status and Quality of Life in Celiac Disease

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

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

Conditions
-----------------
Quality of Life, Celiac Disease, Nutritional Deficiency

Intervention / Treatment
-----------------
* Procedure: Blood draw once a time


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Celiac patients compliant to gluten-free diet (GFD)<br>People with celiac disease who compliant to gluten-free diet (GFD) when they accepted in the study | Procedure: Blood draw once a time<br>* Investigation of intestinal permeability by measuring serum zonulin levels in blood sample<br>|
| Celiac patients non-compliant to gluten-free diet(NGFD)<br>People with celiac disease who noncompliant to the gluten-free diet (NGFD) group when they accepted in the study | Procedure: Blood draw once a time<br>* Investigation of intestinal permeability by measuring serum zonulin levels in blood sample<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum zonulin levels of people with celiac disease | 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. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dietary intake levels of people with celiac disease | Three-day food consumptions of patients were recorded. Food records of each patient were analyzed in Nutrition Program, Nutrition Information Systems (BEBIS) program and daily energy and dietary nutrient intake levels of each patient were calculated. | 1 day | 
| Body weight, fat and muscle mass measurements of people with celiac disease | Body weight (kg), fat mass (kg) and muscle mass (kg) of each patient were measured with a bioelectrical impedance analysis (BIA) based body composition analyzer. | 1 day | 
| Body height, waist and hip circumference measurements of people with celiac disease | Certain anthropometric measurements of each patient were taken. Height (cm) was measured with a stadiometer. Tape measurements of waist circumference (cm) and hip circumference (cm) were recorded. | 1 day | 
| Calculation of waist circumference to hip circumference ratio of people with celiac disease | The ratio of waist circumference to hip circumference was calculated by dividing waist circumference measurement value (cm) to hip circumference measurement value (cm). | 1 day | 
| Quality of life of people with celiac disease | Celiac disease quality of life questionnaire specific to Turkish celiac population was performed. The questionnaire includes twenty eight questions and total point of questionnaire is between 0-196. Total low point indicates low quality of life, high point indicates high quality of life for people with celiac disease. | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
celiac disease, gluten, zonulin, nutritional status, quality of life