Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:53 AM
Ignite Modification Date:
2025-12-25 @ 2:53 AM
NCT ID:
NCT03007433
Eligibility Criteria:
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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)
* 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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT03007433
Study Brief:
Protocol Section:
NCT03007433