Chewing Gum and Gastric Emptying of Water

October 13, 2016 updated by: Lionel Bouvet
The aims of this prospective cross over study was to compare the gastric emptying of 250 ml water in fasting volunteers, in two situations : without chewing gum or while chewing gum during 45 min

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bron, France, 69500
        • Hôpital Femme Mère Enfant - Hospices Civils de Lyon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ASA 1 or 2 volunteers

Exclusion Criteria:

  • digestive diseases, gastroparesis
  • Smokers
  • Pregnancy
  • Diabetes Mellitus
  • Medication affecting gastric motility
  • Previous gastrointestinal surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Controle
The volunteer does not chew gum during the study period
Experimental: Chewing gum
The volunteer chews gum during the first 45 min after ingestion of 250 ml water
Behavioral: 1 chewing gum over 45 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Comparison of the rate of gastric emptying of 250 ml water when chewing or not chewing gum, as assessed by the ultrasound measurement of antral area performed each 20 min
Time Frame: every 20 minutes during 120 min
every 20 minutes during 120 min

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lionel Bouvet

Investigators

  • Principal Investigator: Lionel BOUVET, MD, PhD, Hospices Civils de Lyon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

February 1, 2016

First Submitted That Met QC Criteria

February 1, 2016

First Posted (Estimate)

February 3, 2016

Study Record Updates

Last Update Posted (Estimate)

October 14, 2016

Last Update Submitted That Met QC Criteria

October 13, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • 2016-A00009-42
  • L15-206 (Other Identifier: Comité de Protection des Personnes Sud Est IV)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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