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Functional dyspepsia (FD) is among the most established and common functional gastrointestinal disorders (FGIDs). FD is subdivided into two subtypes based on symptoms: epigastric pain syndrome (EPS) and postprandial distress syndrome (PDS). Based on international guidelines (Asian Consensus and Rome Consensus), a prokinetic, medication which promotes gut movement (such as Itopride) should be the 1st line treatment for the PDS sub-type and a proton pump inhibitor, medication which reduces stomach acid production (such as Esomeprazole) should be the 1st line treatment for the EPS sub-type. However, in the routine practice in Malaysia, proton pump inhibitor is still commonly used as 1st line treatment for FD, regardless of subtypes. This may be one of the reasons why FD continues to be inadequately treated locally and causes poor health-related quality of life (QOL) in FD patients. The purpose of this study is to compare the clinical symptoms and quality of life improvement in patients with functional dyspepsia (FD) after treatment according to international guidelines versus treatment according to routine practice. Adverse effects when managed according to guidelines versus routine practice will also be evaluated.
Age
18 - 80 years
Sex
ALL
Healthy Volunteers
No
University Malaya Medical Centre
Kuala Lumpur, Malaysia
Start Date
November 18, 2021
Primary Completion Date
December 31, 2023
Completion Date
December 31, 2023
Last Updated
May 16, 2023
180
ESTIMATED participants
Treatment based on subtypes: Esomeprazole or Itopride
DRUG
Treatment with proton pump inhibitor regardless of subtype: Esomeprazole
DRUG
Lead Sponsor
University of Malaya
NCT07182890
NCT07196735
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