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

NCT06213948 | Unknown Phase 1 DMC

• 1 other identifier: USM/JEPeM/20120624
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Functional Disorder of Stomach; Healthy

Keywords

Functional dyspepsia; Gastric accommodation; Gastric emptying; Micro inflammation

Outcome Measures

Primary Outcomes (3)

• Gastric volume (fasting and postprandial)

  SPECT/CT volumetry

  Fasting, 10-min. postprandial

• Gastric emptying profile (4 hours)

  Gastric emptying scintigraphy

  Immediately after test meal ingestion, up to 4 hours postprandial

• Intragastric pressure

  High-resolution manometry

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

Secondary Outcomes (2)

• Satiation

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

• Upper gastrointestinal symptoms

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

Other Outcomes (1)

• Standardized Uptake Value (stomach)

  Fasting and 10-min. postprandial

Study Arms (2)

Healthy

EXPERIMENTAL

Drug: Mirtazapine 15 MG

Functional Dyspepsia

EXPERIMENTAL

Drug: Mirtazapine 15 MG

Interventions

Mirtazapine 15 MG DRUG

Mirtazapine * Commercial name: Remeron® SolTab * Pharmaceutical form: film-coated tablets (15 mg)

Functional Dyspepsia; Healthy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• 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

Sponsors & Collaborators

• Universiti Sains Malaysia: lead
• Ministry of Higher Education, Malaysia: collaborator

Study Sites (1)

Hospital Universiti Sains Malaysia

Kota Bharu, Kelantan, 16150, Malaysia

RECRUITING

MeSH Terms

Interventions

Mirtazapine

Intervention Hierarchy (Ancestors)

Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Nashrulhaq Tagiling, MSc

  Universiti Sains Malaysia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Norazlina Mat Nawi, MD, MMed

CONTACT

+609-7676684; norazlina@usm.my

Lee Yeong Yeh, MD, PhD

CONTACT

+609-7673974; yylee@usm.my

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD student

Study Record Dates

• First Submitted: January 9, 2024
• First Posted: January 19, 2024
• Study Start: August 1, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: January 19, 2024

Record last verified: 2024-01

Locations

MY (1)