Elucidating Mechanisms That Underlie the Symptomatology of Functional Dyspepsia Using Novel Techniques and Its Therapeutic Validation Using Neuromodulators

Launched by UNIVERSITI SAINS MALAYSIA · Jan 9, 2024

Keywords

ClinConnect Summary

This clinical trial is designed to explore the underlying causes of functional dyspepsia (FD), a condition that causes symptoms like stomach discomfort and bloating without an obvious medical reason. Researchers will use advanced imaging techniques and tests to understand how the stomach and the first part of the intestine (duodenum) work, focusing on issues like how well the stomach can hold and empty food, and whether there is any inflammation present. The study will also examine if a medication called mirtazapine can help improve these symptoms for those who have FD.

To participate, individuals must be between 18 and 65 years old, and healthy volunteers must not have any current stomach issues or significant medical history. Patients with functional dyspepsia must meet specific criteria confirming their diagnosis and should not have other serious medical conditions. Participants can expect to undergo several tests and imaging procedures, and those diagnosed with FD will receive mirtazapine for four weeks to see if it helps their symptoms. This trial is currently recruiting participants and aims to gather valuable information that could lead to better treatments for functional dyspepsia.

Gender

ALL

Eligibility criteria

• Inclusion Criteria (Healthy):
• • Age 18 and above, up to 65 years old
• • No current GI symptoms (as assessed by history taking during screening and based on the investigators' collective judgement)
• • No previous GI illness (as determined by clinically significant findings from medical history taking and vital signs)
• • No chronic medical illness e.g., chronic neurological, cardiovascular, pulmonary, endoscirne and hematological disorders, as well as psychiatric disorders
• Exclusion Criteria (Healthy):
• • BMI of less than 18.50 and more than 29.99
• • Had undergone any abdominal surgery except appendicectomy, tubal ligation, or Caesarean section
• • Females that are pregnant, expecting to become pregnant during the study period, or breastfeeding
• • Aversion to test meals
• • Use of medications that may alter gastrointestinal function and motility
• • Contraindication for MRI examination e.g., cardiac pacemaker, ferromagnetic implants, claustrophobia
• Inclusion Criteria (FD patients):
• • Age 18 and above, up to 65 years old
• • Satisfy the diagnosis of FD as per Rome IV criteria
• • Absence of organic disorders that explain dyspepsia in patients such as autoimmune disease, inflammatory disease or brain trauma
• • No other chronic medical illnesses (including chronic neurological, cardiovascular, pulmonary, endocrine and hematological disorders) and psychiatric disorders
• Exclusion Criteria (FD patients):
• • Positive Helicobacter pylori test
• • Presence of esophagitis, gastric atrophy, heartburn as predominant symptom, history of peptic ulcer or major abdominal surgery
• • Medications that potentially affects gastrointestinal motility or sensitivity (eg: acid suppressant, prokinetics, corticosteroids, NSAIDs and analgesics apart from paracetamol)
• • Aversion to test meals
• • Recent trauma to the abdomen
• • Patients on antipsychotic or antidepressant in the last 6 weeks
• • Contraindication for MRI examination e.g., cardiac pacemaker, ferromagnetic implants, claustrophobia