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Comorbid Esophageal Disorders in IBS Patients

Primary Purpose

GERD, Non-erosive Reflux Disease, Functional Esophageal Disorders

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Upper endoscopy, esophageal manometry, 24-hour pH monitoring
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for GERD

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Established diagnosis of IBS (according to the Rome criteria of the III revision).
  • Upper GIT symptoms in the form of heartburn (sometimes belching), a lump in the throat, and non-cardiac chest pain.

Exclusion Criteria:

  • History of thoracic, esophageal, or gastric surgery.
  • Presence of duodenal or gastric ulcer on upper endoscopy.
  • Presence of duodenal or gastric cancer on upper endoscopy.
  • Conditions that prevent the installation of a nasogastric tube (nasopharyngeal formation, severe lumen-facial trauma).
  • mental disorders state and disability.
  • Pregnancy and breastfeeding.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    IBS patients who have upper GIT symptoms

    Arm Description

    Outcomes

    Primary Outcome Measures

    Incidence of GERD in IBS patients who have upper GIT symptoms
    use the result of the comprehensive examination, upper endoscopy, esophageal manometry, and 24h pH monitoring to reveal that comorbid disorders of the esophagus in patients with IBS.
    Incidence of Functional esophageal disorders in IBS patient who have upper GIT symptoms.
    use the result of the comprehensive examination, including upper endoscopy, esophageal manometry, and 24h pH monitoring to reveal that comorbid disorders of the esophagus in patients with IBS.

    Secondary Outcome Measures

    Full Information

    First Posted
    January 12, 2021
    Last Updated
    February 13, 2021
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04759378
    Brief Title
    Comorbid Esophageal Disorders in IBS Patients
    Official Title
    Comorbid Disorders of the Esophagus in Patients With Irritable Bowel Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 25, 2021 (Anticipated)
    Primary Completion Date
    September 1, 2021 (Anticipated)
    Study Completion Date
    October 1, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    assess the incidence of the entire spectrum of esophageal disorders and possible theories for overlap in IBS patients using different diagnostic modalities.
    Detailed Description
    In the practice of a gastroenterologist, irritable bowel syndrome (IBS) is the most frequent functional disorder. Its prevalence in the population is 9.8%-12.8%. Its frequency in women is more than men. In some studies, it has been shown that a patient may have an overlap of symptoms of different functional diseases of the gastrointestinal tract. Different researchers have ambiguously assessed the frequency of occurrence of esophageal disorders in patients with IBS. So, based on the publications of different authors, they are found in 15-80% of cases. In a study by N. de Bortoli et al. (2016) noted the association of IBS with functional heartburn in 77% of cases, and with GERD and hypersensitive esophagus (called heartburn associated with reflux) - in 33% of cases. Traditionally, diagnostics of a combination of functional disorders of the esophagus and intestines were based on data X-ray and endoscopic methods. However modern research has shown the importance of using in this group of patients with daily combined pH impedance measurement. Thus, many authors have noted the undoubted advantages of this method in the diagnosis of esophageal disorders. Unfortunately, works devoted to this topic, extremely few in number, and the information obtained in them is quite contradictory, which indicates the need to continue research in this direction.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    GERD, Non-erosive Reflux Disease, Functional Esophageal Disorders, Irritable Bowel Syndrome

    7. Study Design

    Primary Purpose
    Screening
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    IBS patients who have upper GIT symptoms
    Arm Type
    Experimental
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Upper endoscopy, esophageal manometry, 24-hour pH monitoring
    Intervention Description
    upper endoscopy determines if there are structural abnormalities in upper Git. esophageal manometry determines if there are motility disorders. 24-hour pH monitoring determines if acid reflux is present or not, and specifies its rate and duration.
    Primary Outcome Measure Information:
    Title
    Incidence of GERD in IBS patients who have upper GIT symptoms
    Description
    use the result of the comprehensive examination, upper endoscopy, esophageal manometry, and 24h pH monitoring to reveal that comorbid disorders of the esophagus in patients with IBS.
    Time Frame
    baseline
    Title
    Incidence of Functional esophageal disorders in IBS patient who have upper GIT symptoms.
    Description
    use the result of the comprehensive examination, including upper endoscopy, esophageal manometry, and 24h pH monitoring to reveal that comorbid disorders of the esophagus in patients with IBS.
    Time Frame
    baseline

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Established diagnosis of IBS (according to the Rome criteria of the III revision). Upper GIT symptoms in the form of heartburn (sometimes belching), a lump in the throat, and non-cardiac chest pain. Exclusion Criteria: History of thoracic, esophageal, or gastric surgery. Presence of duodenal or gastric ulcer on upper endoscopy. Presence of duodenal or gastric cancer on upper endoscopy. Conditions that prevent the installation of a nasogastric tube (nasopharyngeal formation, severe lumen-facial trauma). mental disorders state and disability. Pregnancy and breastfeeding.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    bishoy s shehata, doctor
    Phone
    +201271724586
    Email
    bishoy.shehata77@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    hossam m Abdelwahaab, Lecturer
    Phone
    +201271724586
    Email
    h.mahmoud@aun.edu.eg

    12. IPD Sharing Statement

    Learn more about this trial

    Comorbid Esophageal Disorders in IBS Patients

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