NCT05901740

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 5, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 13, 2023

Completed
18 days until next milestone

Study Start

First participant enrolled

July 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
Last Updated

June 13, 2023

Status Verified

June 1, 2023

Enrollment Period

1 year

First QC Date

June 5, 2023

Last Update Submit

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

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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: 24124323BACKGROUND
  • 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.

    PMID: 16120760BACKGROUND
  • 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.

    PMID: 12776965BACKGROUND
  • 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.

    PMID: 8021568BACKGROUND
  • 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.

    PMID: 32631285BACKGROUND
  • 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.

    PMID: 14638348BACKGROUND
  • 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.

    PMID: 26729546BACKGROUND
  • Schuster MM. Defining and diagnosing irritable bowel syndrome. Am J Manag Care. 2001 Jul;7(8 Suppl):S246-51.

    PMID: 11474909BACKGROUND

MeSH Terms

Conditions

Heartburn

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Mohamed Fawzy Mohamed

CONTACT

Abdelhameed Mohamed Abdelhameed

CONTACT

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