Prevalence of Fuctional Heartburn in Patients With IBS .

Heartburn Clinical Trial

Official title:

Prevalence of Fuctional Heartburn in Patients With IBS .

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05901740
• Other study ID #: Heart burn in IBS Patients
• Status: Not yet recruiting
• Start date: July 1, 2023
• Est. completion date: August 1, 2024

Study information

• Verified date: June 2023
• Source: Assiut University
• Contact: Mohamed Fawzy Mohamed
• Phone: 01060264431
• Email: drmohamed057[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: August 1, 2024
• Est. primary completion date: July 1, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age above 18 years.

2. 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.

Exclusion Criteria:

1. Patients who refuse to contribute in this study.

2. Presence of duodenal or gastric ulcer or cancer on upper endoscopy.

3. cardiac patients.

4. Pregnancy and breastfeeding

Related Conditions & MeSH terms

• Heartburn

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (8)

Bredenoord AJ, Weusten BL, Curvers WL, Timmer R, Smout AJ. Determinants of perception of heartburn and regurgitation. Gut. 2006 Mar;55(3):313-8. doi: 10.1136/gut.2005.074690. Epub 2005 Aug 24. — View Citation

de Bortoli N, Martinucci I, Bellini M, Savarino E, Savarino V, Blandizzi C, Marchi S. Overlap of functional heartburn and gastroesophageal reflux disease with irritable bowel syndrome. World J Gastroenterol. 2013 Sep 21;19(35):5787-97. doi: 10.3748/wjg.v19.i35.5787. — View Citation

Hachem C, Shaheen NJ. Diagnosis and Management of Functional Heartburn. Am J Gastroenterol. 2016 Jan;111(1):53-61; quiz 62. doi: 10.1038/ajg.2015.376. Epub 2016 Jan 5. — View Citation

Holten KB, Wetherington A, Bankston L. Diagnosing the patient with abdominal pain and altered bowel habits: is it irritable bowel syndrome? Am Fam Physician. 2003 May 15;67(10):2157-62. — View Citation

Kay L, Jorgensen T, Jensen KH. The epidemiology of irritable bowel syndrome in a random population: prevalence, incidence, natural history and risk factors. J Intern Med. 1994 Jul;236(1):23-30. doi: 10.1111/j.1365-2796.1994.tb01115.x. — View Citation

Schuster MM. Defining and diagnosing irritable bowel syndrome. Am J Manag Care. 2001 Jul;7(8 Suppl):S246-51. — View Citation

Talley NJ, Dennis EH, Schettler-Duncan VA, Lacy BE, Olden KW, Crowell MD. Overlapping upper and lower gastrointestinal symptoms in irritable bowel syndrome patients with constipation or diarrhea. Am J Gastroenterol. 2003 Nov;98(11):2454-9. doi: 10.1111/j.1572-0241.2003.07699.x. — View Citation

Yao X, Yang Y, Zhang S, Shi Y, Zhang Q, Wang Y. The impact of overlapping functional dyspepsia, belching disorders and functional heartburn on anxiety, depression and quality of life of Chinese patients with irritable bowel syndrome. BMC Gastroenterol. 2020 Jul 6;20(1):209. doi: 10.1186/s12876-020-01357-1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The purpose of this study is to assess prevalence of functional heartburn in IBS patients.	, 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	Baseline