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

April 17, 2020 updated by: Yeşim Öztekin, Marmara University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

44

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Maltepe
      • Istanbul, Maltepe, Turkey, 34
        • Marmara University Institute of Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

People with celiac disease

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dietary intake levels of people with celiac disease
Time Frame: 1 day
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
Time Frame: 1 day
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
Time Frame: 1 day
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
Time Frame: 1 day
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
Time Frame: 1 day
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marmara University

Investigators

  • Principal Investigator: Yeşim Öztekin, Marmara University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 5, 2018

Primary Completion (Actual)

April 11, 2019

Study Completion (Actual)

April 19, 2019

Study Registration Dates

First Submitted

April 12, 2020

First Submitted That Met QC Criteria

April 16, 2020

First Posted (Actual)

April 17, 2020

Study Record Updates

Last Update Posted (Actual)

April 21, 2020

Last Update Submitted That Met QC Criteria

April 17, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09.2018.359
  • SAG-C-YLP-121218-0630 (Other Grant/Funding Number: Marmara University, Scientific Research Committee (MU-BAPKO))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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