Celiac DiseaseIBSonCDNCT05740306
Irritable Bowel Syndrome Overlaping Celiac Disease
An observational study of Celiac Disease and Irritable Bowel Syndrome, run by Centre of Postgraduate Medical Education at 1 site in Poland.
Trial summary
The goal of this prospective observational cohort stuty is to assess the prevalence of overlap irritable bowel syndrome on coeliac disease in patients on gluten-free diet. The main questions it aims to answer are: percentage of the occurrence of irritable bowel syndrome in the population of Polish patients with celiac… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Celiac Disease, Irritable Bowel Syndrome, Overlap Syndrome
- How many people
- 500 participants
- Where
- 1 sitePoland
- Study dates
- 22 Jan 2023to 31 Dec 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients with celiac disease who belong to the Polish Association of People with Celiac Disease and the Gluten-Free Diet will be invited to the study, and participation in the survey will be voluntary. There will be a website questionnaire assessing celiac disease diagnosis appropriateness (confirmed histopathologically and present blood antibody) and GFD adherence. Only patients who have confirmed CD and who are on a restrictive diet will be included in the study. The second part of the questionnaire will be addressed irritable bowel syndrome symptoms such as abdominal pain and changes in bowel habits. It is worth noticing, that in daily medical practice adherence to the diet is a declarative assessment (there are currently no methods of verifying the diet using objective indicators). IBS also is diagnosed only by clinical assessment.
Who may be able to join
- serologically and histologically confirmed celiac disease
- informed consent to the study
Who cannot join
- people who do not follow a gluten-free diet or do not have a diagnosis of celiac disease, but are on a gluten-free diet.
- No consent to participate in the study.
Trial locations and contacts
1 site in 1 country.
Poland1 site
Szpital Bielański im. Jerzego Popiełuszki
Warsaw, Masovian Voivodeship, 01-809
About this study
Official title: Overlap Between Irritable Bowel Syndrome and Celiac Disease - Prospective Survey Study.
The goal of this prospective observational cohort stuty is to assess the prevalence of overlap irritable bowel syndrome on coeliac disease in patients on gluten-free diet.
The main questions it aims to answer are:
- percentage of the occurrence of irritable bowel syndrome in the population of Polish patients with celiac disease on restrictive gluten-free diet
- what is the correlation between the persistence of intestinal symptoms and adherence to a gluten-free diet (according to the patient's assessment) or confirmation of disease remission (based on histopathology or antibody level).
Read the detailed description
Based on the data published so far, we plan to assess the occurrence of irritable bowel syndrome symptoms in patients with serologically and histopathologically confirmed celiac disease who follow a gluten-free diet. The assessment will be based on the data collected in the questionnaire published on the website of the Polish Association of People with Celiac Disease and the Gluten Free Diet, while maintaining anonymity and the principles of the GDPR. All patients with celiac disease will be invited to the study, and participation in the survey will be voluntary. The questions included in the survey include demographic, epidemiological and medical data provided by patients and the Rome IV Criteria.
There is no control group or minimum number of participants. The 2nd Department of Gastroenterology has established cooperation with the Board of the Association, which is particularly interested in conducting this type of study and which will be responsible for the technical part of its conduct. The Board of the Association has the powers granted to it by members to contact in scientific matters in the form of mailing and/or posting surveys on the Association's website. We have obtained permission to establish cooperation in this project. The technical department of the website developers will prepare a survey based on the provided templates, which will be placed on the website and/or individual member accounts. Members who have agreed to participate in such health-promoting campaigns will be informed by e-mail. The data obtained back and transferred to the researchers will be anonymized. We assume 12 months time for survey propagation. In the event of recruitment difficulties, the maximum time allowed for recruitment may be 18 months. At this time, we assume a response of about 10% of the members of the association with over 5,500 members.
The disadvantage of the project is the lack of access to patients' medical data to confirm the declared diagnosis and evidence of disease remission, as well as to assess compliance with the diet.
Nevertheless, taking into account that both the assessment of adherence to the diet is a declarative assessment (there are currently no methods of verifying the diet by means of objective indicators) and the criteria for diagnosing IBS are clinical criteria, we believe that the obtained data will allow us to get closer to the problem of overlapping functional diseases.
In addition, the survey does not allow to exclude other organic causes of ailments.
- Conditions
- Celiac Disease, Irritable Bowel Syndrome, Overlap Syndrome
- Keywords
- celiac disease, IBS, overlap syndrome
- Medical subject headings
- Celiac Disease, Irritable Bowel Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of IBS in CD
assessment with questionaire the symptoms of irritable bowel syndrome in patients with celiac disease
Measured: one-time answer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2023
- Study start22 Jan 2023
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Celiac DiseaseStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre of Postgraduate Medical Education
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05740306
- Sponsor's protocol ID
- 175/2022
- Acronym
- IBSonCD
- Status last verified
- Feb 2023
- First submitted
- 13 Feb 2023
- Last updated
- 23 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Overlap Between Irritable Bowel Syndrome and Celiac Disease - Prospective Survey Study.
- ClinicalTrials.gov ID
- NCT05740306
- Acronym / sponsor ID
- IBSonCD / 175/2022
- Conditions
- Celiac Disease, Irritable Bowel Syndrome, Overlap Syndrome
- Keywords
- celiac disease, IBS, overlap syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Centre of Postgraduate Medical EducationUniversity, hospital or other
- Study start
- 22 Jan 2023 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 23 Feb 2023 (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.
The goal of this prospective observational cohort stuty is to assess the prevalence of overlap irritable bowel syndrome on coeliac disease in patients on gluten-free diet.
The main questions it aims to answer are:
- percentage of the occurrence of irritable bowel syndrome in the population of Polish patients with celiac disease on restrictive gluten-free diet
- what is the correlation between the persistence of intestinal symptoms and adherence to a gluten-free diet (according to the patient's assessment) or confirmation of disease remission (based on histopathology or antibody level).
Detailed description
Based on the data published so far, we plan to assess the occurrence of irritable bowel syndrome symptoms in patients with serologically and histopathologically confirmed celiac disease who follow a gluten-free diet. The assessment will be based on the data collected in the questionnaire published on the website of the Polish Association of People with Celiac Disease and the Gluten Free Diet, while maintaining anonymity and the principles of the GDPR. All patients with celiac disease will be invited to the study, and participation in the survey will be voluntary. The questions included in the survey include demographic, epidemiological and medical data provided by patients and the Rome IV Criteria.
There is no control group or minimum number of participants. The 2nd Department of Gastroenterology has established cooperation with the Board of the Association, which is particularly interested in conducting this type of study and which will be responsible for the technical part of its conduct. The Board of the Association has the powers granted to it by members to contact in scientific matters in the form of mailing and/or posting surveys on the Association's website. We have obtained permission to establish cooperation in this project. The technical department of the website developers will prepare a survey based on the provided templates, which will be placed on the website and/or individual member accounts. Members who have agreed to participate in such health-promoting campaigns will be informed by e-mail. The data obtained back and transferred to the researchers will be anonymized. We assume 12 months time for survey propagation. In the event of recruitment difficulties, the maximum time allowed for recruitment may be 18 months. At this time, we assume a response of about 10% of the members of the association with over 5,500 members.
The disadvantage of the project is the lack of access to patients' medical data to confirm the declared diagnosis and evidence of disease remission, as well as to assess compliance with the diet.
Nevertheless, taking into account that both the assessment of adherence to the diet is a declarative assessment (there are currently no methods of verifying the diet by means of objective indicators) and the criteria for diagnosing IBS are clinical criteria, we believe that the obtained data will allow us to get closer to the problem of overlapping functional diseases.
In addition, the survey does not allow to exclude other organic causes of ailments.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients with celiac disease who belong to the Polish Association of People with Celiac Disease and the Gluten-Free Diet will be invited to the study, and participation in the survey will be voluntary. There will be a website questionnaire assessing celiac disease diagnosis appropriateness (confirmed histopathologically and present blood antibody) and GFD adherence. Only patients who have confirmed CD and who are on a restrictive diet will be included in the study. The second part of the questionnaire will be addressed irritable bowel syndrome symptoms such as abdominal pain and changes in bowel habits. It is worth noticing, that in daily medical practice adherence to the diet is a declarative assessment (there are currently no methods of verifying the diet using objective indicators). IBS also is diagnosed only by clinical assessment.
Key inclusion criteria (2 listed)
- serologically and histologically confirmed celiac disease
- informed consent to the study
Key exclusion criteria (2 listed)
- people who do not follow a gluten-free diet or do not have a diagnosis of celiac disease, but are on a gluten-free diet.
- No consent to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
percentage of IBS in CD
Time frame: one-time answer
assessment with questionaire the symptoms of irritable bowel syndrome in patients with celiac disease
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Irritable Bowel Syndrome, run by Centre of Postgraduate Medical Education at 1 site in Poland.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 23 Feb 2023. 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 Poland. 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?
Results are not available in the source record.
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?
percentage of IBS in CD (time frame: one-time answer). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Feb 2023.