Investigating the causes of functional dyspepsia and testing a treatment
Elucidating Mechanisms That Underlie Symptomatology of Functional Dyspepsia Using Novel Imaging Technique of SPECT/CT, MRI, High-Resolution Manometry and Biomarkers; and the Therapeutic Validation of Elucidated Mechanisms Using Neuromodulator Compounds
This study is trying to understand what causes functional dyspepsia and see if the medication mirtazapine can help people with this condition feel better.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 54 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Universiti Sains Malaysia Academic / other |
| Locations | 1 site (Kota Bharu, Kelantan) |
| Trial ID | NCT06213948 on ClinicalTrials.gov |
What this trial studies
This study aims to explore the mechanisms behind functional dyspepsia, focusing on gastric accommodation, gastric emptying, and micro-inflammation using advanced imaging techniques such as SPECT/CT and MRI. It will also validate these findings through a therapeutic trial using the neuromodulator mirtazapine. The study includes both healthy participants and those with functional dyspepsia to compare results and assess treatment efficacy. The goal is to better understand the condition and improve treatment options for affected patients.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 65 with functional dyspepsia or healthy individuals without gastrointestinal symptoms.
Not a fit: Patients with significant gastrointestinal illnesses or chronic medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for patients suffering from functional dyspepsia.
How similar studies have performed: While there have been studies on functional dyspepsia, this approach using novel imaging techniques and neuromodulators is relatively novel and untested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Kota Bharu, Kelantan
- Hospital Universiti Sains Malaysia — Kota Bharu, Kelantan, Malaysia (Recruiting)
Study contacts
- Principal investigator: Nashrulhaq Tagiling, MSc — Universiti Sains Malaysia
- Study coordinator: Norazlina Mat Nawi, MD, MMed
- Email: norazlina@usm.my
- Phone: +609-7676684
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.