Functional DyspepsiaNCT03007433
Assessment of GI Function to a Large Test Meal by Non-invasive Imaging
A study testing 400ml of Liquid Nutrient Drink in people with Functional Dyspepsia, run by Nottingham University Hospitals NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Functional Dyspepsia
- What is being tested?
- 400ml of Liquid Nutrient Drink
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2010to Feb 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be an adult patient above 18 years old
- Meet the block randomization criteria for age and sex (no such allocation required for patient group)
- Have a body mass index of >18 and <30kg.m2 and not exceed a waist circumference of 99cm at 5cm above ileal crest
- Be able to give voluntary informed consent and from whom written consent to participate has been obtained.
- Be able to understand the study, willing to co-operate with the study procedures and able to attend all study assessments.
- Be willing to abstain from alcohol for 24 hours before and during the imaging appointment.
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- Be willing to fast from midnight prior to the screening and imaging appointment
- Be able to ingest at least 400ml nutrient liquid (0.75kcal/ml at 40ml/min) during a Nutrient Drinking Test without experiencing more than moderate dyspeptic symptoms (no such restriction for patients with dyspeptic symptoms)
- Be willing to consent to their General Practitioner (GP) being informed of their participation.
Who cannot join
- Have a history of gastrointestinal disease or surgery (other than appendicitis or hysterectomy)
- Have ongoing disease requiring active management
- Have a documented history of alcohol or drug abuse
- Fail to satisfy the investigator's assessment of fitness to participate based on a survey of inclusion and exclusion criteria
- Have consumed alcohol within 24 hours of start of study
- Have participated in a similar study involving the use of radioisotopes in the previous 3 months such that participating in the current study would exceed the recommended yearly exposure limit (5mSv)
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- Take any medication which may affect oesophageal or gastric motility for a minimum 7 days
- Have had previous history of gastric surgery
- Have active upper gastrointestinal diseases
- Have an active Eating Disorder
- Have an allergy to milk protein (milk based, lactose free test meal)
- Be a vegan
- Be pregnant or breastfeeding
- Have any contraindication to MRI scanning according to local guidelines
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Nottingham University Hopsitals
Nottingham, Nottinghamshire, NG7 2UH
About this study
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
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.
Read the 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).
- Conditions
- Functional Dyspepsia
- Being tested
- 400ml of Liquid Nutrient Drink
- Keywords
- gastric emptying, functional dyspepsia, non invasive imaging, MRI, gamma scintigraphy, gastroparesis
- Medical subject headings
- Gastroparesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
400ml of Liquid Nutrient DrinkOther
Also called Fortisip Vanilla
12MBq Technetium-99m-DTPA will be added as a non-absorbable marker incorporated into liquid nutrient drink Fortisip Vanilla (Nutricia Clinical)
| Study group | Role | What they receive |
|---|---|---|
| healthy volunteers | Experimental | 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. Receives: Other: 400ml of Liquid Nutrient Drink |
| Functional dyspeptic patients | Experimental | 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 Receives: Other: 400ml of Liquid Nutrient Drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of gastric sensory function using the nutrient drink test for volume ingested at maximum satiation
Measured: 4 months from consent
Estimate steady state gastric emptying rate (ml/min) using Gamma Scintigraphy And Magnetic Resonance Imaging (MRI)
Measured: 4 months from consent
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2017 (estimated)
- Study startOct 2010
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional DyspepsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nottingham University Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark R Fox, MD, Principal investigator, Univeristy Hopsitals Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03007433
- Sponsor's protocol ID
- 10GA007
- Other IDs
- 10/H0408/52
- Status last verified
- Dec 2016
- First submitted
- 21 Nov 2016
- Last updated
- 2 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03007433
- Acronym / sponsor ID
- 10GA007
- Conditions
- Functional Dyspepsia
- Keywords
- gastric emptying, functional dyspepsia, non invasive imaging, MRI, gamma scintigraphy, gastroparesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Nottingham University Hospitals NHS TrustUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 2 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| healthy volunteers | Experimental | Other: 400ml of Liquid Nutrient Drink60 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. |
| Functional dyspeptic patients | Experimental | Other: 400ml of Liquid Nutrient Drink20 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Be an adult patient above 18 years old
- Meet the block randomization criteria for age and sex (no such allocation required for patient group)
- Have a body mass index of >18 and <30kg.m2 and not exceed a waist circumference of 99cm at 5cm above ileal crest
- Be able to give voluntary informed consent and from whom written consent to participate has been obtained.
- Be able to understand the study, willing to co-operate with the study procedures and able to attend all study assessments.
Key exclusion criteria (14 listed)
- Have a history of gastrointestinal disease or surgery (other than appendicitis or hysterectomy)
- Have ongoing disease requiring active management
- Have a documented history of alcohol or drug abuse
- Fail to satisfy the investigator's assessment of fitness to participate based on a survey of inclusion and exclusion criteria
- Have consumed alcohol within 24 hours of start of study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 400ml of Liquid Nutrient DrinkAlso: Fortisip Vanilla12MBq Technetium-99m-DTPA will be added as a non-absorbable marker incorporated into liquid nutrient drink Fortisip Vanilla (Nutricia Clinical) | Other | Functional dyspeptic patients, healthy volunteers |
Primary outcome
Assessment of gastric sensory function using the nutrient drink test for volume ingested at maximum satiation
Time frame: 4 months from consent
Estimate steady state gastric emptying rate (ml/min) using Gamma Scintigraphy And Magnetic Resonance Imaging (MRI)
Time frame: 4 months from consent
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2017.
Related trials for Functional Dyspepsia
Enrolling by invitationObservational study
Body Surface Gastric Mapping to Evaluate Patients With Upper Gastrointestinal Symptoms and Controls
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Efficacy of Clostridium Butyricum in Alleviating Anxiety and Depression in Patients With Functional Dyspepsia
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Exploring Novel Therapeutic Approaches for Disorders of Gut-Liver-Brain Interaction-H1/H2
Functional Gastrointestinal Disorders
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Interactive Effects of Early-Life Stress, Diet, and Metabolism on Gastrointestinal Dysfunction With Neuropsychiatric Symptoms
Irritable Bowel Syndrome (IBS), Functional Dyspepsia
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark R Fox, MD principal investigator
Univeristy Hopsitals Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 400ml of Liquid Nutrient Drink in people with Functional Dyspepsia, run by Nottingham University Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of gastric sensory function using the nutrient drink test for volume ingested at maximum satiation (time frame: 4 months from consent). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2017.