Celiac DiseaseNCT04351828
Intestinal Permeability, Nutritional Status and Quality of Life in Celiac Disease
An observational study of Celiac Disease and Nutritional Deficiency, run by Marmara University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Celiac Disease, Nutritional Deficiency, Quality of Life
- What is being tested?
- Blood draw once a time
- Type of treatment
- Surgery or procedure
- How many people
- 44 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Nov 2018to 19 Apr 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Study population: People with celiac disease
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Marmara University Institute of Health Sciences
Istanbul, Maltepe, 34
About this study
Official title: 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.
Read the 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.
- Conditions
- Celiac Disease, Nutritional Deficiency, Quality of Life
- Being tested
- Blood draw once a time
- Keywords
- celiac disease, gluten, zonulin, nutritional status, quality of life
- Medical subject headings
- Celiac Disease, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood draw once a timeProcedure or surgery
Investigation of intestinal permeability by measuring serum zonulin levels in blood sample
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Blood draw once a time | |
| 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 Receives: Procedure: Blood draw once a time |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2020
- Study start5 Nov 2018
- Primary completion11 Apr 2019
- Study completion19 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (29)Papers the sponsor has linked to this study.
- Other trials for Celiac DiseaseStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yeşim Öztekin, Marmara University
- Investigators
- Yeşim Öztekin, Principal investigator, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04351828
- Sponsor's protocol ID
- 09.2018.359
- Other IDs
- SAG-C-YLP-121218-0630
- Status last verified
- Apr 2020
- First submitted
- 12 Apr 2020
- Last updated
- 21 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ajamian M, Steer D, Rosella G, Gibson PR. Serum zonulin as a marker of intestinal mucosal barrier function: May not be what it seems. PLoS One. 2019 Jan 14;14(1):e0210728. doi: 10.1371/journal.pone.0210728. eCollection 2019.
PubMed 30640940Bai JC, Ciacci C. World Gastroenterology Organisation Global Guidelines: Celiac Disease February 2017. J Clin Gastroenterol. 2017 Oct;51(9):755-768. doi: 10.1097/MCG.0000000000000919. No abstract available.
PubMed 28877080Burger JPW, de Brouwer B, IntHout J, Wahab PJ, Tummers M, Drenth JPH. Systematic review with meta-analysis: Dietary adherence influences normalization of health-related quality of life in coeliac disease. Clin Nutr. 2017 Apr;36(2):399-406. doi: 10.1016/j.clnu.2016.04.021. Epub 2016 Apr 30.
PubMed 27179800C D, Berry N, Vaiphei K, Dhaka N, Sinha SK, Kochhar R. Quality of life in celiac disease and the effect of gluten-free diet. JGH Open. 2018 Jun 6;2(4):124-128. doi: 10.1002/jgh3.12056. eCollection 2018 Aug.
PubMed 30483576Fasano A. Intestinal zonulin: open sesame! Gut. 2001 Aug;49(2):159-62. doi: 10.1136/gut.49.2.159. No abstract available.
PubMed 11454785Fasano A. Intestinal permeability and its regulation by zonulin: diagnostic and therapeutic implications. Clin Gastroenterol Hepatol. 2012 Oct;10(10):1096-100. doi: 10.1016/j.cgh.2012.08.012. Epub 2012 Aug 16.
PubMed 22902773Ludvigsson JF, Leffler DA, Bai JC, Biagi F, Fasano A, Green PH, Hadjivassiliou M, Kaukinen K, Kelly CP, Leonard JN, Lundin KE, Murray JA, Sanders DS, Walker MM, Zingone F, Ciacci C. The Oslo definitions for coeliac disease and related terms. Gut. 2013 Jan;62(1):43-52. doi: 10.1136/gutjnl-2011-301346. Epub 2012 Feb 16.
PubMed 22345659Schumann M, Siegmund B, Schulzke JD, Fromm M. Celiac Disease: Role of the Epithelial Barrier. Cell Mol Gastroenterol Hepatol. 2017 Jan 14;3(2):150-162. doi: 10.1016/j.jcmgh.2016.12.006. eCollection 2017 Mar.
PubMed 28275682Theethira TG, Dennis M, Leffler DA. Nutritional consequences of celiac disease and the gluten-free diet. Expert Rev Gastroenterol Hepatol. 2014 Feb;8(2):123-9. doi: 10.1586/17474124.2014.876360.
PubMed 24417260Vici G, Belli L, Biondi M, Polzonetti V. Gluten free diet and nutrient deficiencies: A review. Clin Nutr. 2016 Dec;35(6):1236-1241. doi: 10.1016/j.clnu.2016.05.002. Epub 2016 May 7.
PubMed 27211234Duerksen DR, Wilhelm-Boyles C, Veitch R, Kryszak D, Parry DM. A comparison of antibody testing, permeability testing, and zonulin levels with small-bowel biopsy in celiac disease patients on a gluten-free diet. Dig Dis Sci. 2010 Apr;55(4):1026-31. doi: 10.1007/s10620-009-0813-5. Epub 2009 Apr 28.
PubMed 19399613Aksan A, Mercanligil SM, Hauser W, Karaismailoglu E. Validation of the Turkish version of the Celiac Disease Questionnaire (CDQ). Health Qual Life Outcomes. 2015 Jun 19;13:82. doi: 10.1186/s12955-015-0272-y.
PubMed 26088079Barone M, Della Valle N, Rosania R, Facciorusso A, Trotta A, Cantatore FP, Falco S, Pignatiello S, Viggiani MT, Amoruso A, De Filippis R, Di Leo A, Francavilla R. A comparison of the nutritional status between adult celiac patients on a long-term, strictly gluten-free diet and healthy subjects. Eur J Clin Nutr. 2016 Jan;70(1):23-7. doi: 10.1038/ejcn.2015.114. Epub 2015 Jul 15.
PubMed 26173865Duerksen DR, Wilhelm-Boyles C, Parry DM. Intestinal permeability in long-term follow-up of patients with celiac disease on a gluten-free diet. Dig Dis Sci. 2005 Apr;50(4):785-90. doi: 10.1007/s10620-005-2574-0.
PubMed 15844719Fasano A, Not T, Wang W, Uzzau S, Berti I, Tommasini A, Goldblum SE. Zonulin, a newly discovered modulator of intestinal permeability, and its expression in coeliac disease. Lancet. 2000 Apr 29;355(9214):1518-9. doi: 10.1016/S0140-6736(00)02169-3.
PubMed 10801176
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Investigation of Nutritional Status, Intestinal Permeability and Quality of Life in People With Celiac Disease
- ClinicalTrials.gov ID
- NCT04351828
- Acronym / sponsor ID
- 09.2018.359
- Conditions
- Celiac Disease, Nutritional Deficiency, Quality of Life
- Keywords
- celiac disease, gluten, zonulin, nutritional status, quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 5 Nov 2018 (actual)
- Primary completion
- 11 Apr 2019 (actual)
- Study completion
- 19 Apr 2019 (actual)
- First posted
- 17 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Celiac patients compliant to gluten-free diet (GFD) | – | Procedure: Blood draw once a timePeople with celiac disease who compliant to gluten-free diet (GFD) when they accepted in the study |
| Celiac patients non-compliant to gluten-free diet(NGFD) | – | Procedure: Blood draw once a timePeople with celiac disease who noncompliant to the gluten-free diet (NGFD) group when they accepted in the study |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- People with celiac disease
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood draw once a timeInvestigation of intestinal permeability by measuring serum zonulin levels in blood sample | Procedure or surgery | Celiac patients compliant to gluten-free diet (GFD), Celiac patients non-compliant to gluten-free diet(NGFD) |
Primary outcome
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.
5 secondary outcomes
Dietary intake levels of people with celiac disease
Time frame: 1 day
Body weight, fat and muscle mass measurements of people with celiac disease
Time frame: 1 day
Body height, waist and hip circumference measurements of people with celiac disease
Time frame: 1 day
Calculation of waist circumference to hip circumference ratio of people with celiac disease
Time frame: 1 day
Quality of life of people with celiac disease
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2020.
- Background: PubMed 30640940Ajamian M, Steer D, Rosella G, Gibson PR. Serum zonulin as a marker of intestinal mucosal barrier function: May not be what it seems. PLoS One. 2019 Jan 14;14(1):e0210728. doi: 10.1371/journal.pone.0210728. eCollection 2019.
- Background: PubMed 28877080Bai JC, Ciacci C. World Gastroenterology Organisation Global Guidelines: Celiac Disease February 2017. J Clin Gastroenterol. 2017 Oct;51(9):755-768. doi: 10.1097/MCG.0000000000000919. No abstract available.
- Background: PubMed 27179800Burger JPW, de Brouwer B, IntHout J, Wahab PJ, Tummers M, Drenth JPH. Systematic review with meta-analysis: Dietary adherence influences normalization of health-related quality of life in coeliac disease. Clin Nutr. 2017 Apr;36(2):399-406. doi: 10.1016/j.clnu.2016.04.021. Epub 2016 Apr 30.
- Background: PubMed 30483576C D, Berry N, Vaiphei K, Dhaka N, Sinha SK, Kochhar R. Quality of life in celiac disease and the effect of gluten-free diet. JGH Open. 2018 Jun 6;2(4):124-128. doi: 10.1002/jgh3.12056. eCollection 2018 Aug.
- Background: PubMed 11454785Fasano A. Intestinal zonulin: open sesame! Gut. 2001 Aug;49(2):159-62. doi: 10.1136/gut.49.2.159. No abstract available.
- Background: PubMed 22902773Fasano A. Intestinal permeability and its regulation by zonulin: diagnostic and therapeutic implications. Clin Gastroenterol Hepatol. 2012 Oct;10(10):1096-100. doi: 10.1016/j.cgh.2012.08.012. Epub 2012 Aug 16.
- Background: PubMed 22345659Ludvigsson JF, Leffler DA, Bai JC, Biagi F, Fasano A, Green PH, Hadjivassiliou M, Kaukinen K, Kelly CP, Leonard JN, Lundin KE, Murray JA, Sanders DS, Walker MM, Zingone F, Ciacci C. The Oslo definitions for coeliac disease and related terms. Gut. 2013 Jan;62(1):43-52. doi: 10.1136/gutjnl-2011-301346. Epub 2012 Feb 16.
- Background: PubMed 28275682Schumann M, Siegmund B, Schulzke JD, Fromm M. Celiac Disease: Role of the Epithelial Barrier. Cell Mol Gastroenterol Hepatol. 2017 Jan 14;3(2):150-162. doi: 10.1016/j.jcmgh.2016.12.006. eCollection 2017 Mar.
- Background: PubMed 24417260Theethira TG, Dennis M, Leffler DA. Nutritional consequences of celiac disease and the gluten-free diet. Expert Rev Gastroenterol Hepatol. 2014 Feb;8(2):123-9. doi: 10.1586/17474124.2014.876360.
- Background: PubMed 27211234Vici G, Belli L, Biondi M, Polzonetti V. Gluten free diet and nutrient deficiencies: A review. Clin Nutr. 2016 Dec;35(6):1236-1241. doi: 10.1016/j.clnu.2016.05.002. Epub 2016 May 7.
- Results publication: PubMed 19399613Duerksen DR, Wilhelm-Boyles C, Veitch R, Kryszak D, Parry DM. A comparison of antibody testing, permeability testing, and zonulin levels with small-bowel biopsy in celiac disease patients on a gluten-free diet. Dig Dis Sci. 2010 Apr;55(4):1026-31. doi: 10.1007/s10620-009-0813-5. Epub 2009 Apr 28.
- Results publication: PubMed 26088079Aksan A, Mercanligil SM, Hauser W, Karaismailoglu E. Validation of the Turkish version of the Celiac Disease Questionnaire (CDQ). Health Qual Life Outcomes. 2015 Jun 19;13:82. doi: 10.1186/s12955-015-0272-y.
- World Health Organization (WHO) classification of BMILink provided by the sponsor.
- Dietary Guidelines for Turkey (TUBER)Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yeşim Öztekin principal investigator
Marmara University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Celiac Disease and Nutritional Deficiency, run by Marmara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum zonulin levels of people with celiac disease (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04351828, which also lists 29 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2020.