Functional Disorder of StomachPhase 1NCT06213948
Elucidating Mechanisms That Underlie the Symptomatology of Functional Dyspepsia Using Novel Techniques and Its Therapeutic Validation Using Neuromodulators
A Phase 1 study testing Mirtazapine 15 MG in people with Functional Disorder of Stomach and Healthy, run by Universiti Sains Malaysia at 1 site in Malaysia.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Functional Disorder of Stomach, Healthy
- What is being tested?
- Mirtazapine 15 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Aug 2021to 31 Dec 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Malaysia1 site, 1 recruiting
- Recruiting
Hospital Universiti Sains Malaysia
Kota Bharu, Kelantan, 16150
Nashrulhaq Tagiling, MSc, +609-7676684, nashrulhaq17@student.usm.my
Nashrulhaq Tagiling, MSc
About this study
Official title: 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
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
- Conditions
- Functional Disorder of Stomach, Healthy
- Being tested
- Mirtazapine 15 MG
- Keywords
- Functional dyspepsia, Gastric accommodation, Gastric emptying, Micro inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mirtazapine 15 MGDrug
Mirtazapine
- Commercial name: Remeron® SolTab
- Pharmaceutical form: film-coated tablets (15 mg)
| Study group | Role | What they receive |
|---|---|---|
| Healthy | Experimental | Not described Receives: Drug: Mirtazapine 15 MG |
| Functional Dyspepsia | Experimental | Not described Receives: Drug: Mirtazapine 15 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastric volume (fasting and postprandial)
SPECT/CT volumetry
Measured: Fasting, 10-min. postprandial
Gastric emptying profile (4 hours)
Gastric emptying scintigraphy
Measured: Immediately after test meal ingestion, up to 4 hours postprandial
Intragastric pressure
High-resolution manometry
Measured: Fasting, up to 30-min. postprandial after reaching maximum tolerated volume
Secondary outcomes (2)
Satiation
Satiation scale
Measured: Fasting, up to 30-min. postprandial after reaching maximum tolerated volume
Upper gastrointestinal symptoms
Visual analog scale
Measured: Fasting, up to 30-min. postprandial after reaching maximum tolerated volume
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2024
- Study start1 Aug 2021
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional Disorder of StomachStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiti Sains Malaysia
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Higher Education, Malaysia
- Responsible party
- Principal investigator, Nashrulhaq Tagiling, MSc, Universiti Sains Malaysia
- Investigators
- Nashrulhaq Tagiling, MSc, Principal investigator, Universiti Sains Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06213948
- Sponsor's protocol ID
- USM/JEPeM/20120624
- Status last verified
- Jan 2024
- First submitted
- 9 Jan 2024
- Last updated
- 19 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD sharing has yet to be discussed thoroughly with co-investigators.
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06213948
- Acronym / sponsor ID
- USM/JEPeM/20120624
- Conditions
- Functional Disorder of Stomach, Healthy
- Keywords
- Functional dyspepsia, Gastric accommodation, Gastric emptying, Micro inflammation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Universiti Sains MalaysiaUniversity, hospital or other
- Collaborators
- Ministry of Higher Education, Malaysia
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 19 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy | Experimental | Drug: Mirtazapine 15 MG |
| Functional Dyspepsia | Experimental | Drug: Mirtazapine 15 MG |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mirtazapine 15 MGMirtazapine * Commercial name: Remeron® SolTab * Pharmaceutical form: film-coated tablets (15 mg) | Drug | Functional Dyspepsia, Healthy |
Primary outcome
Gastric volume (fasting and postprandial)
Time frame: Fasting, 10-min. postprandial
SPECT/CT volumetry
Gastric emptying profile (4 hours)
Time frame: Immediately after test meal ingestion, up to 4 hours postprandial
Gastric emptying scintigraphy
Intragastric pressure
Time frame: Fasting, up to 30-min. postprandial after reaching maximum tolerated volume
High-resolution manometry
2 secondary outcomes
Satiation
Time frame: Fasting, up to 30-min. postprandial after reaching maximum tolerated volume
Upper gastrointestinal symptoms
Time frame: Fasting, up to 30-min. postprandial after reaching maximum tolerated volume
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2024.
- Individual participant dataSharing planned: Undecided. IPD sharing has yet to be discussed thoroughly with co-investigators.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nashrulhaq Tagiling, MSc principal investigator
Universiti Sains Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Mirtazapine 15 MG in people with Functional Disorder of Stomach and Healthy, run by Universiti Sains Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Norazlina Mat Nawi, MD, MMed (+609-7676684, norazlina@usm.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastric volume (fasting and postprandial) (time frame: Fasting, 10-min. postprandial). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2024.