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

Last updated: January 9, 2024
Sponsor: Universiti Sains Malaysia
Overall Status: Active - Recruiting

Phase

1

Condition

Colic

Heartburn

Bowel Dysfunction

Treatment

Mirtazapine 15 MG

Clinical Study ID

NCT06213948
USM/JEPeM/20120624
  • Ages 18-65
  • All Genders
  • Accepts Healthy Volunteers

Study 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

Eligibility Criteria

Inclusion

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

Study Design

Total Participants: 54
Treatment Group(s): 1
Primary Treatment: Mirtazapine 15 MG
Phase: 1
Study Start date:
August 01, 2021
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • Hospital Universiti Sains Malaysia

    Kota Bharu, Kelantan 16150
    Malaysia

    Active - Recruiting

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