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
About this trial
This is an interventional screening trial for GERD
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.
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
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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