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

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04351828
• Other study ID #: 09.2018.359
• Secondary ID: SAG-C-YLP-121218
• Status: Completed
• Start date: November 5, 2018
• Est. completion date: April 19, 2019

Study information

• Verified date: April 2020
• Source: Marmara University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: April 19, 2019
• Est. primary completion date: April 11, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Celiac Disease
• Malnutrition
• Nutritional Deficiency
• Quality of Life

Intervention

Procedure:
• Blood draw once a time
Investigation of intestinal permeability by measuring serum zonulin levels in blood sample

Locations

Country	Name	City	State
Turkey	Marmara University Institute of Health Sciences	Istanbul	Maltepe

Sponsors (1)

Lead Sponsor	Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

References & Publications (29)

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* Note: There are 29 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   Dietary Guidelines for Turkey (TUBER)
•   World Health Organization (WHO) classification of BMI