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UnknownNCT05901740

Prevalence of Fuctional Heartburn in Patients With IBS .

Status
Unknown
Phase
Study type
Observational
Enrollment
100 (estimated)
Sponsor
Assiut University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers

Summary

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

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)

Conditions

Timeline

Start date
2023-07-01
Primary completion
2024-07-01
Completion
2024-08-01
First posted
2023-06-13
Last updated
2023-06-13

Source: ClinicalTrials.gov record NCT05901740. Inclusion in this directory is not an endorsement.