Prevalence of Fuctional Heartburn in Patients With IBS .

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05901740
Collaborator
(none)
100
13

Study Details

Study Description

Brief Summary

The purpose of this study is to assess prevalence of functional heartburn in IBS patients.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Functional heartburn (FH) and IBS are functional digestive disorders that may occur in the same patients (1).

    Heartburn is a burning sensation in the chest, radiating toward the mouth, as a result of acid reflux into the esophagus. However, only a small percentage of reflux events are symptomatic. Heartburn is also often associated with a sour taste in the back of the mouth with or without regurgitation of the refluxate.(2) Definition of FH has been greatly modified from the Rome II criteria (in which the definition of FH included all NERD patients with negative pH-manometry) to the Rome III criteria (in which FH is defined as a functional esophageal disorder unrelated to GERD and characterized by negative pH-manometry, the lack of a relationship between symptoms and reflux events, and the lack of symptom improvement after a trial of PPI therapy)(2).

    However, data establishing a solid link between FH and IBS are lacking, because the clinical definition of FH has undergone substantial changes over the years(3). the prevalence of IBS varied from 5 to 65% and the incidence varied from 1 to 36% , Its frequency in women is more than men.(4). Psychological problems were strongly associated with prevalence and incidence of IBS. (5) Distinguishing between irritable bowel syndrome (IBS) and functional dyspepsia can be challenging because of the variations in symptom patterns, which commonly overlap.(6) Currently, The criteria for diagnosis of Functional heartburn (FH) rest not only on compatible symptoms but also on exclusion of structural and metabolic disorders that might mimic the functional disorders, Patients have to have a normal X_ray ,normal upper endoscopy and 24-hour PH monitoring test that is normal, and the absence of any evidence of a correlation between physiologic reflux events, either weakly acidic or acidic, and heartburn symptoms.(7,8)

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Other
    Time Perspective:
    Cross-Sectional
    Official Title:
    Prevalence of Fuctional Heartburn in Patients With IBS .
    Anticipated Study Start Date :
    Jul 1, 2023
    Anticipated Primary Completion Date :
    Jul 1, 2024
    Anticipated Study Completion Date :
    Aug 1, 2024

    Outcome Measures

    Primary Outcome Measures

    1. The purpose of this study is to assess prevalence of functional heartburn in IBS patients. [Baseline]

      , The criteria for diagnosis of Functional heartburn (FH) rest not only on compatible symptoms but also on exclusion of structural and metabolic disorders that might mimic the functional disorders, Patients have to have a normal X_ray ,normal upper endoscopy and 24-hour PH monitoring test that is normal, and the absence of any evidence of a correlation between physiologic reflux events, either weakly acidic or acidic, and heartburn symptoms

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    1. Age above 18 years.

    2. Patients diagonsed as IBS (according to the Rome criteria of the lV revision) and presented with heartburn with a normal X_ray, normal upper endoscopy and normal 24-hour PH monitoring.

    Exclusion Criteria:
    1. Patients who refuse to contribute in this study.

    2. Presence of duodenal or gastric ulcer or cancer on upper endoscopy.

    3. cardiac patients.

    4. Pregnancy and breastfeeding

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Assiut University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Mohamed fawzy, Resident, Assiut University
    ClinicalTrials.gov Identifier:
    NCT05901740
    Other Study ID Numbers:
    • Heart burn in IBS Patients
    First Posted:
    Jun 13, 2023
    Last Update Posted:
    Jun 13, 2023
    Last Verified:
    Jun 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 13, 2023