Assessment of GI Function to a Large Test Meal by Non-invasive Imaging
Condition: Functional Dyspepsia
MeSH terms: Dyspepsia
Study type: Interventional

Summary: 
      Dyspeptic symptoms such as abdominal pain, bloating and nausea after a meal are common;
      however the cause of these problems in many patients is often unclear despite medical
      investigation. This is because "dyspeptic symptoms" are only rarely related to acid reflux,
      stomach ulcers or cancer that can be diagnosed by endoscopy. Rather, the cause is abnormal
      stomach function, so-called "functional dyspepsia", a condition in which the digestive system
      does not function normally after a meal. Gastric scintigraphy is the standard investigation
      of stomach function in patients with this condition. It involves eating a small test meal
      that includes a tiny dose of radioactive material so that the movement of food can be
      visualised as it empties from the stomach. An important limitation of this approach is that
      symptoms are rarely caused and delayed emptying after a small meal is present only in a
      minority of patients and, thus, the ability of this investigation to explain the cause of
      symptoms or guide medical treatment is limited.

      This research project is designed to compare three new investigations of stomach function
      using a relatively large meal. This information will help to explain the causes of symptoms
      after a meal. The investigations to be tested include: (1) Nutrient Drink Test, (2) Gastric
      Scintigraphy and (3) Magnetic Resonance Imaging. All three tests are safe, easy to perform
      and non-invasive (i.e. do not involve inserting catheters through the nose and into the
      stomach or taking blood). The results should provide more useful information to doctors
      looking after patients with dyspeptic symptoms.

      This study will compare test results from healthy volunteers, with patients attending clinic
      for investigation of dyspeptic symptoms. The aim is to document abnormal function of the
      stomach and intestines and to identify the causes of dyspeptic symptoms after a meal.
    

Detailed description: 
      The Nutrient Drinking Test will be performed as part of the screening visit to ensure that
      all patients that consent to participate in the full study are able to complete the imaging
      studies that require ingestion of 400ml liquid nutrient (Fortisip Vanilla (Nutricia Clinical)
      diluted 1:1 with water to 0.75kcal/ml, 4.5g fat/100ml).

      Subjects will drink one from a series of beakers containing 40ml liquid nutrient every
      minute. During the drinking test, subjects will score satiety, fullness, bloating, heartburn,
      nausea and epigastric pain at 5-min intervals using a 100mm visual analogue scale (sample
      attached). Participants will be instructed to cease intake when they reported maximal satiety
      or very severe dyspeptic symptoms (defined as VAS score of >90 mm). The total volume ingested
      will be recorded. Symptoms will be assessed again 15 and 30 min after cessation of intake.

      If the subject fulfils the inclusion and exclusion criteria including ingestion of ≥400ml at
      the drinking test and consents to continue then appointments will be made for gamma
      scintigraphy and MRI studies according to a prospective randomization plan.

      MRI Study Day After eligibility has been confirmed subjects will ingest the paramagnetic
      contrast labelled liquid nutrient test meal according to a standardized protocol. Subjects
      will drink one from a series of ten beakers containing 40ml liquid nutrient every minute.
      During the test meal, subjects will score satiety, fullness, bloating, heartburn, nausea and
      epigastric pain at baseline, 5 and 10 minute using a visual analogue scale (VAS 0-100 mm).
      These measurements will be repeated at 30min and at the conclusion of the imaging study (see
      below).

      Studies will be performed using a 1.5T whole MRI system (Intera, Philips, Best, The
      Netherlands). Six rectangular surface coils (height = 20 cm, width = 10 cm), fixed around the
      abdomen and connected to independent receive channels were used for signal detection.

      Gamma Scintigraphy Study Day After eligibility has been confirmed subjects will ingest the
      radiolabelled liquid nutrient test meal according to a standardized protocol. Subjects will
      drink one from a series of ten beakers containing 40ml liquid nutrient every minute. During
      the test meal, subjects will score satiety, fullness, bloating, heartburn, nausea and
      epigastric pain at baseline, 5 and 10 min using a visual analogue scale (VAS 0-100 mm).
    

Intervention name(s): 400ml of Liquid Nutrient Drink
Intervention type(s): Other
Intervention description(s): 12MBq Technetium-99m-DTPA will be added as a non-absorbable marker incorporated into liquid nutrient drink Fortisip Vanilla (Nutricia Clinical)
Other intervention name(s): Fortisip Vanilla
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: gastric emptying; functional dyspepsia; non invasive imaging; MRI; gamma scintigraphy; gastroparesis