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临床试验/NCT05901740
NCT05901740尚未招募不适用

Prevalence of Fuctional Heartburn in Patients With IBS .

Assiut University0 个研究点目标入组 100 人开始时间: 2023年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
主要终点
The purpose of this study is to assess prevalence of functional heartburn in IBS patients.

研究概览

简要总结

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

详细描述

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)

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Age above 18 years.
  • •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.

排除标准

  • •Patients who refuse to contribute in this study.
  • •Presence of duodenal or gastric ulcer or cancer on upper endoscopy.
  • •cardiac patients.
  • •Pregnancy and breastfeeding

结局指标

主要结局

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

时间窗: 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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohamed fawzy

Resident

Assiut University

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