A Phase 1 interventional study of Mirtazapine 15 MG in Functional Disorder of Stomach and Healthy, sponsored by Universiti Sains Malaysia. Recruiting at 1 site in Malaysia. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-19.
Sponsored by Universiti Sains Malaysia · Phase 1, Interventional, and Basic science
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:
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
Inclusion Criteria (Healthy):
Exclusion Criteria (Healthy):
Inclusion Criteria (FD patients):
Exclusion Criteria (FD patients):
Drug: Mirtazapine 15 MG
Drug: Mirtazapine 15 MG
Mirtazapine * Commercial name: Remeron® SolTab * Pharmaceutical form: film-coated tablets (15 mg)
Gastric volume (fasting and postprandial)
SPECT/CT volumetry
Time frame: Fasting, 10-min. postprandial
Gastric emptying profile (4 hours)
Gastric emptying scintigraphy
Time frame: Immediately after test meal ingestion, up to 4 hours postprandial
Intragastric pressure
High-resolution manometry
Time frame: Fasting, up to 30-min. postprandial after reaching maximum tolerated volume
Satiation
Satiation scale
Time frame: Fasting, up to 30-min. postprandial after reaching maximum tolerated volume
Upper gastrointestinal symptoms
Visual analog scale
Time frame: Fasting, up to 30-min. postprandial after reaching maximum tolerated volume
Standardized Uptake Value (stomach)
SPECT/CT quantitative imaging
Time frame: Fasting and 10-min. postprandial
Plan to share: Undecided — IPD sharing has yet to be discussed thoroughly with co-investigators.
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Universiti Sains Malaysia