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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06213948
Other study ID # USM/JEPeM/20120624
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date August 1, 2021
Est. completion date December 31, 2025

Study information

Verified date January 2024
Source Universiti Sains Malaysia
Contact Norazlina Mat Nawi, MD, MMed
Phone +609-7676684
Email norazlina@usm.my
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Recruiting
Enrollment 54
Est. completion date December 31, 2025
Est. primary completion date December 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Malaysia Hospital Universiti Sains Malaysia Kota Bharu Kelantan

Sponsors (2)

Lead Sponsor Collaborator
Universiti Sains Malaysia Ministry of Higher Education, Malaysia

Country where clinical trial is conducted

Malaysia, 

Outcome

Type Measure Description Time frame Safety issue
Other Standardized Uptake Value (stomach) SPECT/CT quantitative imaging Fasting and 10-min. postprandial
Primary Gastric volume (fasting and postprandial) SPECT/CT volumetry Fasting, 10-min. postprandial
Primary Gastric emptying profile (4 hours) Gastric emptying scintigraphy Immediately after test meal ingestion, up to 4 hours postprandial
Primary Intragastric pressure High-resolution manometry Fasting, up to 30-min. postprandial after reaching maximum tolerated volume
Secondary Satiation Satiation scale Fasting, up to 30-min. postprandial after reaching maximum tolerated volume
Secondary Upper gastrointestinal symptoms Visual analog scale Fasting, up to 30-min. postprandial after reaching maximum tolerated volume
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