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

Universiti Sains Malaysia

Status and phase

Enrolling

Phase 1

Conditions

Healthy

Functional Disorder of Stomach

Treatments

Drug: Mirtazapine 15 MG

Study type

Interventional

Funder types

Other

Identifiers

NCT06213948

USM/JEPeM/20120624

Details and patient eligibility

About

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

Enrollment

54 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and 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