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

Phase 1

Recruiting

• Conditions: Functional Disorder of Stomach; Healthy
• Interventions: Drug: Mirtazapine 15 MG

• Registration Number: NCT06213948
• Lead Sponsor: Universiti Sains Malaysia

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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-01
• Status Verified: 2024-01
• Study First Submitted: 2024-01-09
• Study First Submitted QC: 2024-01-09
• Last Update Submitted: 2024-01-09
• Study First Posted: 2024-01-19
• Last Update Posted: 2024-01-19
• Primary Completion: 2024-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy	Mirtazapine 15 MG	-
Functional Dyspepsia	Mirtazapine 15 MG	-

Primary Outcome Measures

Name	Time	Method
Gastric volume (fasting and postprandial)	Fasting, 10-min. postprandial	SPECT/CT volumetry
Gastric emptying profile (4 hours)	Immediately after test meal ingestion, up to 4 hours postprandial	Gastric emptying scintigraphy
Intragastric pressure	Fasting, up to 30-min. postprandial after reaching maximum tolerated volume	High-resolution manometry

Secondary Outcome Measures

Name	Time	Method
Satiation	Fasting, up to 30-min. postprandial after reaching maximum tolerated volume	Satiation scale
Upper gastrointestinal symptoms	Fasting, up to 30-min. postprandial after reaching maximum tolerated volume	Visual analog scale

Trial Locations

Locations (1)

Hospital Universiti Sains Malaysia; 🇲🇾 Kota Bharu, Kelantan, Malaysia