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Abbott Vital® as an Alternative Meal to the Gold-standard Egg-white Sandwich for Gastric Emptying Scintigraphy (GES)

U

Universiti Sains Malaysia

Status

Completed

Conditions

Healthy

Treatments

Radiation: Abbott Vital®
Radiation: Egg-white sandwich

Study type

Observational

Funder types

Other

Identifiers

NCT04812301
USM/JEPeM/20120684

Details and patient eligibility

About

This crossover study is designed to compare the rates of gastric emptying between two diagnostic radioactive meals using the gold-standard egg-white sandwich meal and Abbott Vital®. Healthy participants will be recruited and randomly assigned into either groups of Abbott Vital® and gold-standard egg-white sandwich group. The measurements will be performed over a 4-hour period using a gamma camera, and estimated gastric emptying rates will be calculated using established algorithms.

Full description

The gold-standard egg-white sandwich is quite difficult and complicated for staffs to prepare because the food needs to be cooked first and it will take time to prepare. Besides, the egg-white sandwich is not suitable for those with allergies to egg and bread and also to vegetarian patients. This gold-standard meal is also not a common meal for Asian people so some of the people may not tolerate with the meal. The aim of this study is to determine whether Abbott Vital® is as reliable as the gold-standard egg-white sandwich by comparing the gastric meal retention of both meals.

Enrollment

30 patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Normal body mass index (BMI)
  • Able to give consent
  • 18 years old above

Exclusion criteria

  • Vegetarian
  • Allergy or cannot tolerate with milk, egg, and bread
  • Participants with past and current history of chronic medical illness
  • Currently on medication that can affect gastrointestinal function are also excluded

Trial design

30 participants in 2 patient groups

Group 1
Description:
Egg-white sandwich is added with 1 mCi Tc-99m sodium phytate, then Abbott Vital® added with 1 mCi Tc-99m sodium phytate
Treatment:
Radiation: Egg-white sandwich
Radiation: Abbott Vital®
Group 2
Description:
Abbott Vital® is added with 1 mCi Tc-99m sodium phytate, then egg-white sandwich added with 1 mCi Tc-99m sodium phytate
Treatment:
Radiation: Egg-white sandwich
Radiation: Abbott Vital®

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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