Status:
RECRUITING
Elucidating Mechanisms That Underlie the Symptomatology of Functional Dyspepsia Using Novel Techniques and Its Therapeutic Validation Using Neuromodulators
Lead Sponsor:
Universiti Sains Malaysia
Collaborating Sponsors:
Ministry of Higher Education, Malaysia
Conditions:
Functional Disorder of Stomach
Healthy
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief 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, gastr...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
August 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT06213948
Start Date
August 1 2021
End Date
December 31 2025
Last Update
January 19 2024
Active Locations (1)
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1
Hospital Universiti Sains Malaysia
Kota Bharu, Kelantan, Malaysia, 16150