Condition category
Digestive System
Date applied
09/01/2020
Date assigned
15/01/2020
Last edited
05/02/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Preoperative fasting is routinely applied before any procedure with general anaesthesia, with the goal of avoiding the risk of aspiration of gastric contents into the trachea (breathing tube). However, the safe limits for ingestion are not well defined. Studies in children suggest that a limited quantity of semisolid food, e.g. milk products, may be eliminated from the stomach well within a fasting period of 4 hours, which is shorter than the currently prescribed 6 hours. The primary aim of this study is to investigate if a set amount of milk-based drink is eliminated from the stomach within 4 hours of ingestion. The secondary aims are to investigate if there is a difference in gastric content after drinking low- or high-fat yoghurt, and to validate ultrasound for determining the gastric content volume after 4 hours of fasting.

Who can participate?
Adult patients who have been referred to the Endoscopy Unit at Uppsala University Hospital for endoscopic examination of the stomach (gastroscopy)

What does the study involve?
In the first phase of the study, 100 adults scheduled for a gastroscopy (investigation of the stomach with a fibreoptic camera) are instructed to drink one glass (250 ml) or two glasses (500 ml) of milk 4 hours before the planned procedure. During the gastroscopy, any gastric content is suctioned into a container and analysed with respect to volume and type of content (clear, milk-stained or solid content). The procedure then continues according to the clinical routine. In the second phase of the study, a different set of 100 adults scheduled for gastroscopy are instructed to drink a fixed volume of either low-fat (50 kcal/100 ml) or high-fat yoghurt (100 kcal/100 ml). The volume will be either 250 ml or 500 ml, depending on the results of the first phase of the study. The gastroscopy is carried out as for the first group above. In addition, an ultrasound examination of the stomach is performed to determine the type and estimate the volume of any residual content. This ultrasound examination is performed immediately before the gastroscopy.

What are the possible benefits and risks of participating?
Participating in the study does not give any possible benefits. There are no known risks of participating. The gastroscopy is performed as per routine, with the exception that the initial contents of the stomach are suctioned out at the beginning of the procedure instead of at the end. The ultrasound examination is non-invasive and painless, and poses no risks to the participant.

Where is the study run from?
Uppsala University Hospital (Sweden)

When is the study starting and how long is it expected to run for?
The planning of the study started in May 2018. The first inclusion of participants is planned for January 20th, 2020. The study is expected to run for approximately 12 months.

Who is funding the study?
Uppsala University Hospital (Sweden)

Who is the main contact?
Dr Peter Frykholm
peter.frykholm@surgsci.uu.se

Trial website

Contact information

Type

Public

Primary contact

Dr Peter Frykholm

ORCID ID

http://orcid.org/0000-0001-6402-136X

Contact details

Dep. of Surgical Sciences
Section of Anaesthesiology and intensive care medicine
Uppsala
75185
Sweden
+46 (0)18 6171240
peter.frykholm@surgsci.uu.se

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

1

Study information

Scientific title

Is gastric emptying complete 4 hours after intake of 250 or 500 ml milk or yoghurt?

Acronym

GMILK

Study hypothesis

Gastric emptying of 250 ml milk or yoghurt is complete within 4 hours of intake.

Ethics approval

Approved 18/08/2018, Uppsala Regional Ethics Committee (Box 1964, 751 49 Uppsala, Sweden; correspondence should be sent to the new Swedish Ethics Review Authority, Box 2120, 750 02 Uppsala, Sweden), ref: 2018/286

Study design

Prospective observational cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Available on request from the principal investigator. Available only in Swedish.

Condition

Adult patients referred for gastroscopy due to gastrointestinal complaints or other symptoms

Intervention

In the first phase of the study, 100 adults scheduled for gastroscopy are instructed to drink one glass (250 ml) or two glasses (500 ml) of milk 4 hours before the planned procedure. During the gastroscopy, any gastric content is suctioned into a container and analysed with respect to volume and type of content (clear, milk-stained or solid content). This is the endpoint of the study, and the procedure then continues according to the clinical routine.

In the second phase of the study, a different set of 100 adults scheduled for gastroscopy are instructed to drink a fixed volume of either low-fat (50 kcal/100ml) or high-fat yoghurt (100 kcal/100ml). The volume will be either 250 ml or 500 ml, depending on the results of the first phase of the study. The gastroscopy part of the protocol is as for the first group above. In addition, an ultrasound examination of the stomach is performed to determine the type and estimate the volume of any residual content. This ultrasound examination is performed immediately before the gastroscopy.

Intervention type

Other

Phase

Drug names

Primary outcome measure

The volume of milk-stained or solid gastric content in ml, 4 hours after ingestion of milk or yoghurt, that can be suctioned from the stomach, measured as soon as the endoscope enters the stomach

Secondary outcome measures

1. The volume of gastric content in ml, estimated with ultrasound, 4 hours after ingestion of milk or yoghurt and immediately before gastroscopy, compared with the volume suctioned through the endoscope the first time it enters the stomach
2. The volume of gastric content in ml, 4 hours after ingestion of low-fat or high-fat yoghurt, measured as soon as the endoscope enters the stomach

Overall trial start date

01/05/2018

Overall trial end date

01/05/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Adult patients referred for gastroscopy because of gastrointestinal symptoms

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

200

Participant exclusion criteria

1. Age < 18 years
2. Age > 60 years
3. Body mass index > 30
4. Condition known to be associated with delayed gastric emptying

Recruitment start date

20/01/2020

Recruitment end date

20/01/2021

Locations

Countries of recruitment

Sweden, Switzerland

Trial participating centre

Endoscopy unit, Uppsala University Hospital
Sjukhusvägen 1
Uppsala
75185
Sweden

Sponsor information

Organisation

Uppsala University Hospital

Sponsor details

Sjukhusvägen 1
Uppsala
75185
Sweden
+46 (0)18 6110000
peter.frykholm@akademiska.se

Sponsor type

Hospital/treatment centre

Website

http://www.akademiska.se/

Funders

Funder type

University/education

Funder name

Uppsala Universitet

Alternative name(s)

Uppsala University

Funding Body Type

private sector organisation

Funding Body Subtype

Universities (academic only)

Location

Sweden

Results and Publications

Publication and dissemination plan

The results will be presented at scientific meetings and published in a peer-reviewed scientific journal in 2021

IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Peter Frykholm (peter.frykholm@surgsci.uu.se). The patients have consented to sharing anonymised data on a group level. Researchers or peer reviewers may also obtain anonymised raw data. The data will be saved up to 10 years after publication.

Intention to publish date

01/06/2021

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

05/02/2020: Uploaded protocol (not peer reviewed) as an additional file. 09/01/2020: Trial's existence confirmed by Uppsala Regional Ethics Committee.