Irritable Bowel Syndrome Overlaping Celiac Disease (IBSonCD)

February 13, 2023 updated by: Centre of Postgraduate Medical Education

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).

Study Overview

Status

Enrolling by invitation

Conditions

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 Type

Observational

Enrollment (Anticipated)

500

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

  • Poland
    • Mazowieckie
      • Warszawa, Mazowieckie, Poland, 01-809
        • Szpital Bielański im. Jerzego Popiełuszki

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • serologically and histologically confirmed celiac disease
  • informed consent to the study

Exclusion Criteria:

  • 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.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
percentage of IBS in CD
Time Frame: one-time answer
assessment with questionaire the symptoms of irritable bowel syndrome in patients with celiac disease
one-time answer

Collaborators and Investigators

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

Sponsor

Centre of Postgraduate Medical Education

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)

January 22, 2023

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

February 13, 2023

First Submitted That Met QC Criteria

February 13, 2023

First Posted (Estimate)

February 23, 2023

Study Record Updates

Last Update Posted (Estimate)

February 23, 2023

Last Update Submitted That Met QC Criteria

February 13, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 175/2022

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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