Prevalence of Fuctional Heartburn in Patients With IBS .
1 other identifier
observational
100
0 countries
N/A
Brief Summary
The purpose of this study is to assess prevalence of functional heartburn in IBS patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2023
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
June 5, 2023
CompletedFirst Posted
Study publicly available on registry
June 13, 2023
CompletedStudy Start
First participant enrolled
July 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2024
CompletedJune 13, 2023
June 1, 2023
1 year
June 5, 2023
June 5, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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
Eligibility Criteria
The Data will be collected by a questionnaire includes the many dimensions ,one of the most important dimensions is symptoms, including typical and atypical symptoms of GERD. Another assessment dimension is the response to treatment, in which the change in severity and/or frequency of symptoms is measured. A third assessment dimension is diagnosis, a tool to discriminate patients with GERD from other diseases. Also, disease-specific quality of life, the burden of GERD on the quality of life of patients, is an assessment dimension of GERD.
You may qualify if:
- 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.
You may not qualify if:
- Patients who refuse to contribute in this study.
- Presence of duodenal or gastric ulcer or cancer on upper endoscopy.
- cardiac patients.
- Pregnancy and breastfeeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (8)
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.
PMID: 24124323BACKGROUNDBredenoord 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.
PMID: 16120760BACKGROUNDHolten 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.
PMID: 12776965BACKGROUNDKay 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.
PMID: 8021568BACKGROUNDYao 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.
PMID: 32631285BACKGROUNDTalley 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.
PMID: 14638348BACKGROUNDHachem 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.
PMID: 26729546BACKGROUNDSchuster MM. Defining and diagnosing irritable bowel syndrome. Am J Manag Care. 2001 Jul;7(8 Suppl):S246-51.
PMID: 11474909BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Resident
Study Record Dates
First Submitted
June 5, 2023
First Posted
June 13, 2023
Study Start
July 1, 2023
Primary Completion
July 1, 2024
Study Completion
August 1, 2024
Last Updated
June 13, 2023
Record last verified: 2023-06