NCT02673307

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 1, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 3, 2016

Completed
27 days until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

October 14, 2016

Status Verified

October 1, 2016

Enrollment Period

7 months

First QC Date

February 1, 2016

Last Update Submit

October 13, 2016

Conditions

Comparison of Gastric Emptying Rate of Water When Chewing Gum or Not

Outcome Measures

Primary Outcomes (1)

  • 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

    every 20 minutes during 120 min

Study Arms (2)

Controle

NO INTERVENTION

The volunteer does not chew gum during the study period

Chewing gum

EXPERIMENTAL

The volunteer chews gum during the first 45 min after ingestion of 250 ml water

Behavioral: 1 chewing gum over 45 minutes

Interventions

1 chewing gum over 45 minutesBEHAVIORAL
Chewing gum

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA 1 or 2 volunteers

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Femme Mère Enfant - Hospices Civils de Lyon

Bron, 69500, France

Location

Related Publications (1)

  • Bouvet L, Loubradou E, Desgranges FP, Chassard D. Effect of gum chewing on gastric volume and emptying: a prospective randomized crossover study. Br J Anaesth. 2017 Nov 1;119(5):928-933. doi: 10.1093/bja/aex270.

    PMID: 29077816DERIVED

Study Officials

  • Lionel BOUVET, MD, PhD

    Hospices Civils de Lyon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

February 1, 2016

First Posted

February 3, 2016

Study Start

March 1, 2016

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

October 14, 2016

Record last verified: 2016-10

Locations

FR(1)