<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03007433</url>
  </required_header>
  <id_info>
    <org_study_id>10GA007</org_study_id>
    <secondary_id>10/H0408/52</secondary_id>
    <nct_id>NCT03007433</nct_id>
  </id_info>
  <brief_title>Assessment of GI Function to a Large Test Meal by Non-invasive Imaging</brief_title>
  <official_title>Assessment of Gastric Motor and Sensory Function to a Large Test Meal by Gamma Scintigraphy, Magnetic Resonance Imaging and a Nutrient Drink Test in Health and Patients With Functional Dyspepsia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nottingham University Hospitals NHS Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nottingham University Hospitals NHS Trust</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Dyspeptic symptoms such as abdominal pain, bloating and nausea after a meal are common;&#xD;
      however the cause of these problems in many patients is often unclear despite medical&#xD;
      investigation. This is because &quot;dyspeptic symptoms&quot; are only rarely related to acid reflux,&#xD;
      stomach ulcers or cancer that can be diagnosed by endoscopy. Rather, the cause is abnormal&#xD;
      stomach function, so-called &quot;functional dyspepsia&quot;, a condition in which the digestive system&#xD;
      does not function normally after a meal. Gastric scintigraphy is the standard investigation&#xD;
      of stomach function in patients with this condition. It involves eating a small test meal&#xD;
      that includes a tiny dose of radioactive material so that the movement of food can be&#xD;
      visualised as it empties from the stomach. An important limitation of this approach is that&#xD;
      symptoms are rarely caused and delayed emptying after a small meal is present only in a&#xD;
      minority of patients and, thus, the ability of this investigation to explain the cause of&#xD;
      symptoms or guide medical treatment is limited.&#xD;
&#xD;
      This research project is designed to compare three new investigations of stomach function&#xD;
      using a relatively large meal. This information will help to explain the causes of symptoms&#xD;
      after a meal. The investigations to be tested include: (1) Nutrient Drink Test, (2) Gastric&#xD;
      Scintigraphy and (3) Magnetic Resonance Imaging. All three tests are safe, easy to perform&#xD;
      and non-invasive (i.e. do not involve inserting catheters through the nose and into the&#xD;
      stomach or taking blood). The results should provide more useful information to doctors&#xD;
      looking after patients with dyspeptic symptoms.&#xD;
&#xD;
      This study will compare test results from healthy volunteers, with patients attending clinic&#xD;
      for investigation of dyspeptic symptoms. The aim is to document abnormal function of the&#xD;
      stomach and intestines and to identify the causes of dyspeptic symptoms after a meal.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Nutrient Drinking Test will be performed as part of the screening visit to ensure that&#xD;
      all patients that consent to participate in the full study are able to complete the imaging&#xD;
      studies that require ingestion of 400ml liquid nutrient (Fortisip Vanilla (Nutricia Clinical)&#xD;
      diluted 1:1 with water to 0.75kcal/ml, 4.5g fat/100ml).&#xD;
&#xD;
      Subjects will drink one from a series of beakers containing 40ml liquid nutrient every&#xD;
      minute. During the drinking test, subjects will score satiety, fullness, bloating, heartburn,&#xD;
      nausea and epigastric pain at 5-min intervals using a 100mm visual analogue scale (sample&#xD;
      attached). Participants will be instructed to cease intake when they reported maximal satiety&#xD;
      or very severe dyspeptic symptoms (defined as VAS score of &gt;90 mm). The total volume ingested&#xD;
      will be recorded. Symptoms will be assessed again 15 and 30 min after cessation of intake.&#xD;
&#xD;
      If the subject fulfils the inclusion and exclusion criteria including ingestion of ≥400ml at&#xD;
      the drinking test and consents to continue then appointments will be made for gamma&#xD;
      scintigraphy and MRI studies according to a prospective randomization plan.&#xD;
&#xD;
      MRI Study Day After eligibility has been confirmed subjects will ingest the paramagnetic&#xD;
      contrast labelled liquid nutrient test meal according to a standardized protocol. Subjects&#xD;
      will drink one from a series of ten beakers containing 40ml liquid nutrient every minute.&#xD;
      During the test meal, subjects will score satiety, fullness, bloating, heartburn, nausea and&#xD;
      epigastric pain at baseline, 5 and 10 minute using a visual analogue scale (VAS 0-100 mm).&#xD;
      These measurements will be repeated at 30min and at the conclusion of the imaging study (see&#xD;
      below).&#xD;
&#xD;
      Studies will be performed using a 1.5T whole MRI system (Intera, Philips, Best, The&#xD;
      Netherlands). Six rectangular surface coils (height = 20 cm, width = 10 cm), fixed around the&#xD;
      abdomen and connected to independent receive channels were used for signal detection.&#xD;
&#xD;
      Gamma Scintigraphy Study Day After eligibility has been confirmed subjects will ingest the&#xD;
      radiolabelled liquid nutrient test meal according to a standardized protocol. Subjects will&#xD;
      drink one from a series of ten beakers containing 40ml liquid nutrient every minute. During&#xD;
      the test meal, subjects will score satiety, fullness, bloating, heartburn, nausea and&#xD;
      epigastric pain at baseline, 5 and 10 min using a visual analogue scale (VAS 0-100 mm).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2010</start_date>
  <completion_date type="Actual">February 2012</completion_date>
  <primary_completion_date type="Actual">February 2012</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Assessment of gastric sensory function using the nutrient drink test for volume ingested at maximum satiation</measure>
    <time_frame>4 months from consent</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Estimate steady state gastric emptying rate (ml/min) using Gamma Scintigraphy And Magnetic Resonance Imaging (MRI)</measure>
    <time_frame>4 months from consent</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">61</enrollment>
  <condition>Functional Dyspepsia</condition>
  <arm_group>
    <arm_group_label>healthy volunteers</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>60 healthy volunteers with no functional dyspepsia as defined by the Rome Questionnaire and no more than mild symptoms on maximum 1 days a week on the GSRS, that meet inclusion and exclusion criteria will be recruited. Eligible subjects will be block randomized by sex and age such that 10 men and women in each age group (&lt;40, 41-60, &gt;60) are recruited.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Functional dyspeptic patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>20 patients with functional dyspepsia with postprandial distress syndrome as defined by the Rome IV Questionnaire and at least moderate symptom severity on at least 3 days a week that meet the inclusion and exclusion criteria will be recruited to provide pilot data in the local patient population</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>400ml of Liquid Nutrient Drink</intervention_name>
    <description>12MBq Technetium-99m-DTPA will be added as a non-absorbable marker incorporated into liquid nutrient drink Fortisip Vanilla (Nutricia Clinical)</description>
    <arm_group_label>Functional dyspeptic patients</arm_group_label>
    <arm_group_label>healthy volunteers</arm_group_label>
    <other_name>Fortisip Vanilla</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Be an adult patient above 18 years old&#xD;
&#xD;
          -  Meet the block randomization criteria for age and sex (no such allocation required for&#xD;
             patient group)&#xD;
&#xD;
          -  Have a body mass index of &gt;18 and &lt;30kg.m2 and not exceed a waist circumference of&#xD;
             99cm at 5cm above ileal crest&#xD;
&#xD;
          -  Be able to give voluntary informed consent and from whom written consent to&#xD;
             participate has been obtained.&#xD;
&#xD;
          -  Be able to understand the study, willing to co-operate with the study procedures and&#xD;
             able to attend all study assessments.&#xD;
&#xD;
          -  Be willing to abstain from alcohol for 24 hours before and during the imaging&#xD;
             appointment.&#xD;
&#xD;
          -  Be willing to fast from midnight prior to the screening and imaging appointment&#xD;
&#xD;
          -  Be able to ingest at least 400ml nutrient liquid (0.75kcal/ml at 40ml/min) during a&#xD;
             Nutrient Drinking Test without experiencing more than moderate dyspeptic symptoms (no&#xD;
             such restriction for patients with dyspeptic symptoms)&#xD;
&#xD;
          -  Be willing to consent to their General Practitioner (GP) being informed of their&#xD;
             participation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have a history of gastrointestinal disease or surgery (other than appendicitis or&#xD;
             hysterectomy)&#xD;
&#xD;
          -  Have ongoing disease requiring active management&#xD;
&#xD;
          -  Have a documented history of alcohol or drug abuse&#xD;
&#xD;
          -  Fail to satisfy the investigator's assessment of fitness to participate based on a&#xD;
             survey of inclusion and exclusion criteria&#xD;
&#xD;
          -  Have consumed alcohol within 24 hours of start of study&#xD;
&#xD;
          -  Have participated in a similar study involving the use of radioisotopes in the&#xD;
             previous 3 months such that participating in the current study would exceed the&#xD;
             recommended yearly exposure limit (5mSv)&#xD;
&#xD;
          -  Take any medication which may affect oesophageal or gastric motility for a minimum 7&#xD;
             days&#xD;
&#xD;
          -  Have had previous history of gastric surgery&#xD;
&#xD;
          -  Have active upper gastrointestinal diseases&#xD;
&#xD;
          -  Have an active Eating Disorder&#xD;
&#xD;
          -  Have an allergy to milk protein (milk based, lactose free test meal)&#xD;
&#xD;
          -  Be a vegan&#xD;
&#xD;
          -  Be pregnant or breastfeeding&#xD;
&#xD;
          -  Have any contraindication to MRI scanning according to local guidelines&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mark R Fox, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Univeristy Hopsitals Nottingham</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Nottingham University Hopsitals</name>
      <address>
        <city>Nottingham</city>
        <state>Nottinghamshire</state>
        <zip>NG7 2UH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>November 21, 2016</study_first_submitted>
  <study_first_submitted_qc>December 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 2, 2017</study_first_posted>
  <last_update_submitted>December 29, 2016</last_update_submitted>
  <last_update_submitted_qc>December 29, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 2, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>gastric emptying</keyword>
  <keyword>functional dyspepsia</keyword>
  <keyword>non invasive imaging</keyword>
  <keyword>MRI</keyword>
  <keyword>gamma scintigraphy</keyword>
  <keyword>gastroparesis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dyspepsia</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03007433
org study id: 10GA007
secondary id: 10/H0408/52
nct id: NCT03007433
lead sponsor: 
has dmc: No
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.
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).
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Assessment of gastric sensory function using the nutrient drink test for volume ingested at maximum satiation
time frame: 4 months from consent
measure: Estimate steady state gastric emptying rate (ml/min) using Gamma Scintigraphy And Magnetic Resonance Imaging (MRI)
time frame: 4 months from consent
arm group label: healthy volunteers
arm group type: Experimental
description: 60 healthy volunteers with no functional dyspepsia as defined by the Rome Questionnaire and no more than mild symptoms on maximum 1 days a week on the GSRS, that meet inclusion and exclusion criteria will be recruited. Eligible subjects will be block randomized by sex and age such that 10 men and women in each age group (<40, 41-60, >60) are recruited.
arm group label: Functional dyspeptic patients
arm group type: Experimental
description: 20 patients with functional dyspepsia with postprandial distress syndrome as defined by the Rome IV Questionnaire and at least moderate symptom severity on at least 3 days a week that meet the inclusion and exclusion criteria will be recruited to provide pilot data in the local patient population
intervention type: Other
intervention name: 400ml of Liquid Nutrient Drink
description: 12MBq Technetium-99m-DTPA will be added as a non-absorbable marker incorporated into liquid nutrient drink Fortisip Vanilla (Nutricia Clinical)
arm group label: Functional dyspeptic patients
arm group label: healthy volunteers
other name: Fortisip Vanilla
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Mark R Fox, MD
role: Principal Investigator
affiliation: Univeristy Hopsitals Nottingham
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Dyspepsia