Irritable Bowel Syndrome Overlaping Celiac Disease

NCT05740306 | Unknown

• 1 other identifier: 175/2022
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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 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).

Conditions

Celiac Disease; Irritable Bowel Syndrome; Overlap Syndrome

Keywords

celiac disease; IBS; overlap syndrome

Outcome Measures

Primary Outcomes (1)

• percentage of IBS in CD

  assessment with questionaire the symptoms of irritable bowel syndrome in patients with celiac disease

  one-time answer

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre of Postgraduate Medical Education: lead

Study Sites (1)

Szpital Bielański im. Jerzego Popiełuszki

Warsaw, Masovian Voivodeship, 01-809, Poland

Location

MeSH Terms

Conditions

Celiac Disease; Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Colonic Diseases, Functional; Colonic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2023
• First Posted: February 23, 2023
• Study Start: January 22, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: February 23, 2023

Record last verified: 2023-02

Locations

PL (1)