Treatment Outcomes For Functional Dyspepsia Based On Current International Guidelines In Multi-Ethnic Asian Patients

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    180
  • sponsor
    University of Malaya
Updated on 8 December 2021

Summary

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.

Details
Condition Functional Dyspepsia
Treatment Treatment based on subtypes: Esomeprazole or Itopride, Treatment with proton pump inhibitor regardless of subtype: Esomeprazole
Clinical Study IdentifierNCT04918017
SponsorUniversity of Malaya
Last Modified on8 December 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients diagnosed with Functional Dyspepsia using Rome IV diagnostic criteria: patients on prior dyspepsia treatment can be recruited after washout period of 2 weeks
Subject who has ability to provide written informed consent and willingness to comply with the requirement of the protocol
Able to communicate in English, Malay or Mandarin languages

Exclusion Criteria

Patients with known hypersensitivity to Itopride and/or proton pump inhibitors or to any of the excipients of the study medication
Patients with a contraindication to any of the study drugs
Pregnant / breast feeding women
Presence of family history of GI malignancy or alarm features suggested malignancy - e.g. Unintentional weight loss ( 10% of body weight in recent 6 months), GI bleeding
Patients consuming regular Aspirin or NSAIDs (except low-dose Aspirin at a dose of 325 mg/day or less for cardiovascular prophylaxis)
History of erosive esophagitis, peptic ulcer disease within 1 year prior to the screening
History of gastrointestinal (GI) malignancy, primary esophageal motility disorder, documented upper GI surgery
Patients with any hepatobiliary or pancreatic diseases
Patients with severe depression, anxiety, or other psychological disorder
Patients with any terminal disease
Presence of irritable bowel syndrome (Rome IV criteria) or inflammatory bowel disease (IBD)
Other conditions determined by the investigator to be inappropriate for this clinical study
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