ESM in Functional Dyspepsia
DyspepsiaDyspepsia and Other Specified Disorders of Function of StomachBackground: Reliable patient reported outcome measures (PROM's) for symptom assessment in functional dyspepsia (FD) are essential in order to evaluate dyspeptic symptoms, identify potential symptom triggers and optimize therapeutic strategies, since biological markers are unavailable. Currently used symptom assessment methods, i.e. end-of-day or end-of-week questionnaires, have considerable limitations. The Experience Sampling Method (ESM), an electronic questioning method characterized by random and repeated, momentary assessments in the subject's current state and environment, might overcome these limitations. The aim of this study is to assess the validity and reliability of an FD-specific electronic patient-reported outcome measure (ePRO), based on the Experience Sampling Method-principle, for symptom assessment and identification of symptom triggers in patients with functional dyspepsia. Objective: The aim of this study is to assess the validity and reliability of an FD-specific electronic patient-reported outcome measure (ePRO), based on the Experience Sampling Method-principle, for symptom assessment and identification of symptom triggers in patients with functional dyspepsia. In order to measure this, internal consistency, test-retest reliability, concurrent validity and the accuracy to differentiate between dyspeptic patients and healthy controls of the developed ePRO will be assessed. In addition, to objectify specific triggers for the onset of gastrointestinal symptoms in dyspepsia, using the FD-specific ESM tool.
Carbon-13 (13C)-Spirulina Platensis Gastric Emptying Breath Test (GEBT)
DyspepsiaThe purpose of this study is to compare stomach emptying using 13C-Spirulina platensis breath test and scintigraphy in healthy subjects and subjects with dyspepsia. Subjects will eat a standard meal of 2 scrambled eggs, a slice of wheat toast and 8 ounces of skim milk. The eggs will be double labeled with Technetium-99m (99mTc) sulfur colloid and 13C-Spirulina platensis. Scintigraphy is a diagnostic technique in which a two-dimensional picture of internal body tissue is produced through the detection of radiation emitted by a radioactive substance administered into the body. The location of a standard meal in the digestive system will be measured by images of the 99mTc sulfur colloid taken at periodic intervals before and after the standard meal. The 99mTc Sulfur Colloid is approved by the FDA for use in medical diagnostic procedures. Spirulina platensis is blue - green algae, which is very similar to the naturally occurring spirulina sold in health food stores as a dietary supplement. The spirulina platensis has been labeled with the 13C stable isotope. 13C stable isotope labeling is inherently safe as 1.1% of all carbon in our bodies and in the food we eat is 13C. The presence of the 13C will be measured by breath samples at periodic intervals before and after a standard meal. The FDA considers 13C-Spirulina platensis to be investigational for the purposes of this study.
Hedonic Perception and Brain Activity Response to Meal
DyspepsiaThe purpose of this study is to determine the relationship between brain activity and the perception of subjective hedonic sensations in response to a meal using functional MRI.
Endoscopic Tri-Modal Imaging to Distinguish Functional Dyspepsia From Reflux Disease
Gastroesophageal Reflux DiseaseDyspepsia1 moreEndoscopic Tri-Modal Imaging which combines Narrow-band Imaging(NBI), Autofluorescence Imaging (AFI) and White-light Imaging (WLI) could be used to identify the indistinct changes in the gut caused by reflux disease,either acid reflux or bile reflux, which make it possible to differentiate reflux disease from functional dyspepsia (FD).
Lymphocytic Subsets and Cytokine Production With H. Pylori Infection
Duodenal UlcerGastric Ulcer1 moreThe aims of this study are 1) to determine the cytokines produced by both Th1 and Th2 subsets in gastric antral biopsy specimens from Taiwanese patients before and after anti H. pylori therapy; 2) to obtain a detailed phenotypic characterization and distribution pattern of mucosal lymphocytes in H. pylori-associated gastritis and to define possible contributing immune mechanisms responsible for the chronicity of the disease and its associated lesions.
The Effect of Gluten-free Diet in Type 1 Diabetics With Dyspepsia Symptoms
Diabetes MellitusType 13 morePatients with type-1 diabetes are more susceptible to motility-related upper gastrointestinal symptoms. Dietary interventions are one of the treatment pillars for these symptoms. Many gastrointestinal conditions other than celiac disease, are being increasingly treated with gluten-free diet (GFD). The role of GFD in non-celiac type-1 diabetic patients with dyspepsia-like symptoms has not been assessed before. In this study, type 1 diabetes patients with concomitant upper gastrointestinal symptoms will be asked to follow a 1-month GFD to assess changes in upper gastrointestinal symptoms and gastroduodenal motility before and after the dietary intervention.
Assessment of Gastro-Intestinal Function to a Mixed Meal by Non-invasive Imaging
Functional DyspepsiaDiabetic GastroparesisDyspeptic symptoms, such as pain after eating, bloating and nausea all have major impact on quality of life and health care costs. When no structural cause is identified, patients are diagnosed with functional dyspepsia. This trial aims to identify objective abnormalities of stomach function that explain patient's symptoms and establish diagnosis. Another group are diabetic patients who can often develop similar symptoms, labelled as diabetic gastroparesis. In some cases this is associated with delayed gastric emptying but not all. 24 patients with functional dyspepsia will be studied and 24 healthy controls (to establish normal ranges) and 24 diabetic patients with symptoms of functional dyspepsia. The utility of 3 different non-invasive investigations will be assessed. At screening the nutrient drink test (NDT) asks the patient to drink 40ml of milkshake (0.75kcal/ml) every minute and score symptoms every 5 minutes. The patient continues until they reach the maximum tolerated volume. Participants will then be randomized to undergo non-invasive imaging on two separate test days by magnetic resonance imaging (MRI) and gastric scintigraphy MRI will be completed with the patient ingesting 400ml of milkshake (identical to NDT) and 12 agar beads (no additional calories) of known breaking strength. The emptying of the stomach will be visualised with the MRI alongside symptom recording. Gamma scintigraphy will ingest the same meal as for the MRI scan but radioactive labelling will allow the rate of liquid and solid meal emptying to be visualised alongside symptom recording. Additionally, blood sugars will be recorded before nutrient drink test and at 15 and 30 minutes following ingestion of 400ml of milkshake and 12 agar beads. Data will be analyzed to assess the association of objective abnormalities of gastric function and patient symptoms. Additionally the results of non-invasive imaging by MRI and GS will be compared to assess the optimal measurement of gastric function and emptying in this clinical scenario.
Defining Central Circuits of Pain
DyspepsiaThe purpose of the study is to use functional Magnetic Resonance Imaging (MRI) to help us understand what parts of the subject's brain are involved when he experiences visceral pain, or pain in the gut. To stimulate the brain, he will be infused with a liquid meal (Ensure) into his stomach until he is maximally full. Magnetic resonance imaging (MRI) is a technique for making images (pictures) of the brain; it uses magnetic fields and radio waves and is not harmful. This study uses a new investigational technique called functional MRI (fMRI), which is a very fast MRI technique that will allow the investigators to evaluate changes in how blood flows to parts of his brain.
Corticotropin Releasing Hormone (CRH) Responsiveness in Children With Functional Dyspepsia
Functional DyspepsiaChronic abdominal pain is the most common persistent pain condition in children and adolescents, affecting 10-15% of children at any given time. One of the most often diagnosed types of abdominal pain is functional dyspepsia (FD). FD is an abdominal pain or discomfort (e.g., nausea, bloating) in the upper abdomen that does not get better by going to the bathroom. For some people it appears that stress can make FD worse. In adults, stress can cause the release of a hormone called corticotropin releasing hormone (CRH). The release of CRH can cause abdominal pain by affecting how fast things move through a person's stomach and intestines. This makes the organs in the abdomen more sensitive to pain, causing tenderness of the inside lining of the stomach and intestines. Different people react differently when the body releases CRH. Some people have abdominal pain without feeling any stress or anxiety while other people who have a lot of stress or anxiety don't have any abdominal pain. Some people have neither stress, anxiety, or abdominal pain when CRH is released into the body. In order to see how the bodies of children with functional dyspepsia and those without functional dyspepsia react to CRH, we will do a CRH stimulation test. A CRH stimulation test is routinely done in endocrine patients. It is not routinely done for patients with functional dyspepsia or for patients who do not have functional dyspepsia. Part of the CRH stimulation test is giving a synthetic type of corticotropin, Acthrel® (brand name for Corticorelin), as injection. Acthrel® has been approved by the Food and Drug Administration (FDA) for use. The purpose of this research study is to see if there are differences in how the bodies of children with functional dyspepsia react to CRH versus children who don't have functional dyspepsia. Being in this study involves one clinic visit where an IV placed and a CRH stimulation test. In this test the child will be given an injection of CRH and then observed for one hour. During that hour the child will have five blood draws through the IV and will be asked questions about their anxiety and abdominal pain. This visit will take about 4 hours. The following things will happen: Your child will be asked to come to the clinic between 8a.m. and 10a.m. fasting. This means your child will have had nothing to eat or drink for 8 hours before coming to the clinic. If your child is a female ten years of age or older, or has started having periods, a urine pregnancy test will be done before receiving the CRH infusion. You and your child will each be asked to complete a survey that measures your child's anxiety. Your child will have a biofeedback session that will measure your child's stress. In a biofeedback session, sensors are placed on your child's fingers, wrists and forehead. These sensors are connected to a computer that monitors your child's heartbeat, skin temperature and electrical pulses on your child's skin. Your child will have an IV inserted into a vein in his/her arm. Your child may have a cream put on their arm to help with the pain of the IV insertion. The IV will be used to inject the CRH and draw blood. If the IV stops working and blood samples can no longer be drawn from it, your child may have another IV started or blood samples may be drawn by needle stick. Your child will then have 30 minutes to relax. Your child will then have CRH infused through the IV over one minute. Your child will have blood drawn through the IV five times; right before the CRH stimulation test begins and 15, 30, 45 and 60 minutes after the CRH infusion. The total amount of blood drawn for the study will be about 2 ½ tablespoons. Your child will be asked about their abdominal pain, nausea, bloating, stress and anxiety at three separate times during the 60 minutes. Your child's heart rate will be measured throughout the CRH stimulation test.
The Efficacy of Removal of Animal Milk From the Diet in Functional Dyspepsia: A Cross-sectional...
DyspepsiaGastrointestinal System DiseaseThe goal of this observational study is to learn about compare the effect of removing animal milk from diets on the symptoms of FD patients in describe participant population. The main question it aims to answer are: • Can removing milk and dairy from diets be used to treat FD patients? The participants will be divided into two groups and will do the following; removing milk and dairy products under the advice of a dietician without medical treatment receiving medical treatment without restricted diet. Researchers will compare two groups to the effect of removing milk from diet on the symptoms of FD patients.