Functional Dyspepsia, Healthy Volunteers
Conditions
Brief summary
Functional dyspepsia (FD) is a common gastrointestinal disorder which can present with early satiety, postprandial fullness, epigastric pain and burning sensation in the absence of underlying disease. The most troubling symptom is weight loss, prevalent in up to 40% of FD patients and is often associated with impaired gastric accommodation. Gastric accommodation by definition is a reflex, mediated vagally which causes reduction in gastric tone, increased in compliance and increment in gastric volume post meal ingestion. It allows large volumes of liquid or solid ingestion without causing postprandial symptoms. Impairment of gastric accommodation has been linked to gastrointestinal symptoms which includes nausea, bloating, early satiety, weight loss and epigastric pain. There are several studies aimed to assess efficacy in the treatment of functional dyspeptic patients. A myriad of tests can measure gastric accommodation such as gastric barostat and single photon emission computed tomography (SPECT). An alternative study known as the nutrient drink test has also been proposed and can be combined with high-resolution manometry. So far, none of the nuclear medicine centers in Malaysia are providing clinical service for radionuclide gastric accommodation study. The gold standard for gastric accommodation assessment is the gastric barostat method. However, the technique is invasive and caused discomfort to patients. Radionuclide gastric accommodation study using 99mTc-pertechnetate with SPECT/CT is a non-invasive method that can be used to assess patient with FD and enables quantitative evaluation of treatment response to medications. Hence, the role of non-invasive gastric volume assessment with 99mTc-pertechenate SPECT/CT in the evaluation of healthy individuals was studied first, and then compared with intragastric pressure measurements from high-resolution manometry and nutrient drink test.
Interventions
RADIATION99mTc-pertechnetate SPECT/CT
This procedure is similar to standard Meckel's diverticulum scan, with the addition of SPECT/CT acquisition to measure gastric volume.
PROCEDURECombined High-Resolution Manometry-Nutrient Drink Test
Proximal gastric high-resolution manometry was done concurrently with nutrient drink test to measure proximal gastric function.
Sponsors
Universiti Sains Malaysia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
Monocentric, non-randomized sequence, pilot and feasibility study
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
Healthy volunteers Inclusion Criteria: * Patient is above 18 years-old. * No current gastrointestinal symptoms * No previous gastrointestinal illness such as peptic ulcer disease or gastritis * No chronic medical illness such as chronic neurological, cardiovascular, pulmonary, endocrine and hematological disorders * Does not fulfill Rome IV criteria for functional dyspepsia
Exclusion criteria
* • Had undergone any abdominal surgery except appendicectomy, tubal ligation or Caesarean section * Use of medications such as metoclopramide, domperidone, erythromycin and itopride that may alter gastrointestinal function and motility * Pregnant woman
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants completing each procedure | From the initiation of the first study procedure until the completion of the second procedures (up to 30 days) | • Feasibility assessed as technical success (number of participants completing each procedure). |
| Duration (time) of each procedural session | From the initiation of the first study procedure until the completion of the second procedures (up to 30 days) | • Feasibility assessed as procedural duration (time taken to complete one procedure) |
| Incidence of adverse event | From the initiation of the first study procedure until the completion of the second procedures (up to 30 days) | • Tolerability assessed as incidence of adverse event over study period using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dyspeptic symptoms measured using numerical rating scales | During the procedure, 1 day | • Dyspeptic symptom responses: Numerical rating scale with verbal descriptors on 4 symptoms i.e., epigastric pain, bloating, fullness, nausea (from 0 to 3: 0 means no symptoms, 3 means severe). All are to be measured in one session using one instrument and as one outcome. |
| Gastric volume measured using SPECT/CT | During the procedure, 1 day | • Gastric volume (in mL): Fasting state, postprandial state (after single-serving of 250 mL nutrient drink). All are to be measured in one session and as one outcome. |
| Satiation score measured using numerical rating scales | During the procedure, 1 day | • Satiation (presented as satiation-unit): Numerical rating scale with verbal descriptors (from 0 to 5: 0 means not full, 5 means maximum fullness) |
| Proximal gastric pressure measured using high-resolution manometry | During the procedure, 1 day | • Proximal gastric pressure (in mmHg): baseline (fasting) pressure recording, prandial pressure recording, postprandial pressure recording. All are to be measured in one session and as one outcome. |
| Nutrient drink tolerance | During the procedure, 1 day | • Maximum tolerated volume (in mL): Number of drink volume required to achieve satiety |
Countries
Malaysia
Outcome results
None listed