Elucidating Mechanisms That Underlie Symptomatology of Functional Dyspepsia Using Novel Imaging Technique of SPECT/CT, MRI, High-Resolution Manometry and Biomarkers; and the Therapeutic Validation of Elucidated Mechanisms Using Neuromodulator Compounds

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: t
View:

• 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

• 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

Locations
Other Locations
Malaysia
Hospital Universiti Sains Malaysia
RECRUITING
Kota Bharu
Contact Information
Primary
Norazlina Mat Nawi, MD, MMed
norazlina@usm.my
+609-7676684
Backup
Lee Yeong Yeh, MD, PhD
yylee@usm.my
+609-7673974
Time Frame
Start Date: 2021-08-01
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 54
Treatments
Experimental: Healthy
Experimental: Functional Dyspepsia
Related Therapeutic Areas
Sponsors
Collaborators: Ministry of Higher Education, Malaysia
Leads: Universiti Sains Malaysia

This content was sourced from clinicaltrials.gov