UnknownPhase 1

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

Malaysia54 participantsStarted 2021-08-01

Plain-language summary

The goal of this study is to investigate the mechanisms of impaired gastric accommodation and emptying, dysfunctional duodenum, and micro-inflammation using novel imaging techniques of SPECT/CT, gastric emptying scintigraphy, MRI, high-resolution manometry, and inflammatory biomarkers, as well as to validate these mechanisms using a therapeutic trial of neuromodulator (mirtazapine) in functional dyspepsia (FD) and health. The main objective\[s\] it aims to answer are: * to investigate impaired gastric accommodation through SPECT/CT imaging and high-resolution manometry findings of the stomach fundus. * to investigate impaired gastric emptying through gastric emptying scintigraphy * to investigate for a dysfunctional duodenum through MRI imaging of the duodenum. * to investigate micro-inflammation through SPECT/CT standard uptake value (SUV), inflammatory biomarkers (eosinophils, mast cells, IL-6, IL-10) and mucosal barrier marker (E-cadherin). * to investigate if a therapeutic trial of a neuromodulator agent, mirtazapine, ameliorates symptoms of FD through improvement in impaired gastric accommodation. For objectives 1-4, FD patients and healthy volunteers will be consecutively recruited, and all will undergo SPECT/CT, MRI, high-resolution manometry and biomarkers, and data acquired from these tests will be analyzed. For objective 5, the enrolled participants who did all baseline tests/markers are given mirtazapine for four weeks, and all tests/markers, except biomarkers and MRI, are repeated at the end of the trial

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Gastric volume (fasting and postprandial)

Timeframe: Fasting, 10-min. postprandial

Gastric emptying profile (4 hours)

Timeframe: Immediately after test meal ingestion, up to 4 hours postprandial

Intragastric pressure

Timeframe: Fasting, up to 30-min. postprandial after reaching maximum tolerated volume

Trial details

NCT IDNCT06213948

SponsorUniversiti Sains Malaysia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-31

Contact for this trial

Norazlina Mat Nawi, MD, MMed

+609-7676684 norazlina@usm.my

View on ClinicalTrials.gov More Functional Disorder of Stomach trials