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RecruitingNCT06213948Updated Jan 19, 2024

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

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

Phase
Phase 1
Study type
Interventional
Enrollment
54
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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

02

Conditions studied

  • Functional Disorder of Stomach
  • Healthy

Keywords

  • Functional dyspepsia
  • Gastric accommodation
  • Gastric emptying
  • Micro inflammation
03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

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
04

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
54 participants (estimated)

Study arms

  • Experimental
    Healthy

    Drug: Mirtazapine 15 MG

  • Experimental
    Functional Dyspepsia

    Drug: Mirtazapine 15 MG

Interventions

  • DrugMirtazapine 15 MG

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

05

What researchers measure

Primary outcomes

  1. Gastric volume (fasting and postprandial)

    SPECT/CT volumetry

    Time frame: Fasting, 10-min. postprandial

  2. Gastric emptying profile (4 hours)

    Gastric emptying scintigraphy

    Time frame: Immediately after test meal ingestion, up to 4 hours postprandial

  3. Intragastric pressure

    High-resolution manometry

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

Secondary outcomes

  1. Satiation

    Satiation scale

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

  2. Upper gastrointestinal symptoms

    Visual analog scale

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

Other outcomes

  1. Standardized Uptake Value (stomach)

    SPECT/CT quantitative imaging

    Time frame: Fasting and 10-min. postprandial

06

Study locations

1 of 1 sites recruiting
  • Hospital Universiti Sains Malaysia
    Kota Bharu, Kelantan 16150, Malaysia
    • Nashrulhaq Tagiling, MSc · Contact · nashrulhaq17@student.usm.my · +609-7676684
    • Nashrulhaq Tagiling, MSc · Principal investigator
    • Norazlina Mat Nawi, MD, MMed · Sub investigator
    • Lee Yeong Yeh, MD, PhD · Sub investigator
    Recruiting
07

References and documents

Individual participant data

Plan to share: Undecided — IPD sharing has yet to be discussed thoroughly with co-investigators.

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06213948
Lead sponsor
Universiti Sains Malaysia
Collaborators
Ministry of Higher Education, Malaysia
Responsible party
Nashrulhaq Tagiling, MSc (PhD student, Universiti Sains Malaysia) — Principal investigator
First posted
Jan 19, 2024
Start date
Aug 1, 2021
Primary completion
Dec 31, 2024 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Jan 19, 2024

Study contacts

Norazlina Mat Nawi, MD, MMed
Contact
norazlina@usm.my
+609-7676684
Lee Yeong Yeh, MD, PhD
Contact
yylee@usm.my
+609-7673974
Nashrulhaq Tagiling, MSc
principal investigator · Universiti Sains Malaysia

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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