Comorbid Esophageal Disorders in IBS Patients
Comorbid Disorders of the Esophagus in Patients With Irritable Bowel Disease
1 other identifier
interventional
50
0 countries
N/A
Brief Summary
assess the incidence of the entire spectrum of esophageal disorders and possible theories for overlap in IBS patients using different diagnostic modalities.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2021
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 12, 2021
CompletedFirst Posted
Study publicly available on registry
February 18, 2021
CompletedStudy Start
First participant enrolled
February 25, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2021
CompletedFebruary 18, 2021
February 1, 2021
6 months
January 12, 2021
February 13, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
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.
baseline
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.
baseline
Study Arms (1)
IBS patients who have upper GIT symptoms
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- resident doctor at Assiut Univeristy Hospotal
Study Record Dates
First Submitted
January 12, 2021
First Posted
February 18, 2021
Study Start
February 25, 2021
Primary Completion
September 1, 2021
Study Completion
October 1, 2021
Last Updated
February 18, 2021
Record last verified: 2021-02