Assessment of GI Function to a Large Test Meal by Non-invasive Imaging

NCT03007433 | Completed

• 2 other identifiers: 10GA00710/H0408/52
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Functional Dyspepsia

Keywords

gastric emptying; functional dyspepsia; non invasive imaging; MRI; gamma scintigraphy; gastroparesis

Outcome Measures

Primary Outcomes (2)

• Assessment of gastric sensory function using the nutrient drink test for volume ingested at maximum satiation

  4 months from consent

• Estimate steady state gastric emptying rate (ml/min) using Gamma Scintigraphy And Magnetic Resonance Imaging (MRI)

  4 months from consent

Study Arms (2)

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.

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

Other: 400ml of Liquid Nutrient Drink

Interventions

400ml of Liquid Nutrient Drink OTHER

12MBq Technetium-99m-DTPA will be added as a non-absorbable marker incorporated into liquid nutrient drink Fortisip Vanilla (Nutricia Clinical)

Also known as: Fortisip Vanilla

Functional dyspeptic patients; healthy volunteers

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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
• 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)
• 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

Sponsors & Collaborators

• Nottingham University Hospitals NHS Trust: lead

Study Sites (1)

Nottingham University Hopsitals

Nottingham, Nottinghamshire, NG7 2UH, United Kingdom

Location

MeSH Terms

Conditions

Gastroparesis

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mark R Fox, MD

  Univeristy Hopsitals Nottingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2016
• First Posted: January 2, 2017
• Study Start: October 1, 2010
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: January 2, 2017

Record last verified: 2016-12

Locations

GB (1)