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

Launched by UNIVERSITY OF MALAYA · May 29, 2021

Keywords

ClinConnect Summary

This clinical trial is looking at how well different treatments for functional dyspepsia (FD) work in patients from diverse backgrounds in Asia. Functional dyspepsia is a common condition that causes discomfort in the upper abdomen and can be split into two types based on symptoms: one type involves pain, and the other involves discomfort after eating. The study aims to find out if following international treatment guidelines leads to better symptom relief and quality of life compared to the usual treatment practices currently used in Malaysia.

To participate in this trial, individuals aged 18 and older who have been diagnosed with functional dyspepsia are welcome, provided they can communicate in English, Malay, or Mandarin and can give written consent. However, those with certain medical conditions or who are pregnant or breastfeeding cannot join. Participants will receive treatment based on either the recommended international guidelines or the common local practices and will be monitored for improvements in their symptoms and overall well-being. This study hopes to shed light on the best ways to help patients manage their functional dyspepsia effectively.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients diagnosed with Functional Dyspepsia using Rome IV diagnostic criteria: patients on prior dyspepsia treatment can be recruited after washout period of 2 weeks
• • 2. Subject who has ability to provide written informed consent and willingness to comply with the requirement of the protocol
• • 3. Able to communicate in English, Malay or Mandarin languages
• Exclusion Criteria:
• • 1. Patients with known hypersensitivity to Itopride and/or proton pump inhibitors or to any of the excipients of the study medication
• • 2. Patients with a contraindication to any of the study drugs
• • 3. Pregnant / breast feeding women
• • 4. 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
• • 5. Patients consuming regular Aspirin or NSAIDs (except low-dose Aspirin at a dose of 325 mg/day or less for cardiovascular prophylaxis)
• • 6. History of erosive esophagitis, peptic ulcer disease within 1 year prior to the screening
• • 7. History of gastrointestinal (GI) malignancy, primary esophageal motility disorder, documented upper GI surgery
• • 8. Patients with any hepatobiliary or pancreatic diseases
• • 9. Patients with severe depression, anxiety, or other psychological disorder
• • 10. Patients with any terminal disease
• • 11. Presence of irritable bowel syndrome (Rome IV criteria) or inflammatory bowel disease (IBD)
• • 12. Other conditions determined by the investigator to be inappropriate for this clinical study

Trial Officials