Clinical trial NCT04351828: Intestinal Permeability, Nutritional Status and Quality of Life in Celiac Disease
Official title: The Investigation of Nutritional Status, Intestinal Permeability and Quality of Life in People With Celiac Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Celiac Disease
Nutritional Deficiency
Quality of Life
Keywords: celiac disease
gluten
zonulin
nutritional status
quality of life
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2020-04-17
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People with celiac disease

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.

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.

Primary outcomes:
measure: Serum zonulin levels of people with celiac disease
timeFrame: 1 day
Secondary outcomes:
measure: Dietary intake levels of people with celiac disease
timeFrame: 1 day
measure: Body weight, fat and muscle mass measurements of people with celiac disease
timeFrame: 1 day
measure: Body height, waist and hip circumference measurements of people with celiac disease
timeFrame: 1 day
measure: Calculation of waist circumference to hip circumference ratio of people with celiac disease
timeFrame: 1 day
measure: Quality of life of people with celiac disease
timeFrame: 1 day
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University Institute of Health Sciences
state: Maltepe
Study officials:
affiliation: Marmara University
name: Yeşim Öztekin
role: PRINCIPAL_INVESTIGATOR
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