Lollipop on Gastric Emptying | NCT04092049

Studies
Lollipop on Gastric Emptying

NCT04092049

Sponsor

Air Force Military Medical University, China

Status

Completed

Last Update Posted

Apr 17, 2020Actual

Enrollment

20Actual

Phase

Not Applicable

Conditions

Gastric Emptying

Interventions

lollipop

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 21, 2019Actual

Primary Completion Date

Dec 22, 2019Actual

Completion Date

Dec 22, 2019Actual

First Submitted Date

Sep 15, 2019

First Submission Date that Met QC Criteria

Sep 16, 2019

First Posted Date

Sep 17, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 15, 2020

Last Update Posted Date

Apr 17, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Zhihong LU, Professor, Air Force Military Medical University, ChinaPrincipal Investigator

Lead Sponsor

Air Force Military Medical University, ChinaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To investigate the effect of chewing lollipop on gastric volume and gastric emptying in healthy volunteers drinking water.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
lollipop	Experimental		Other: lollipop
control	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
lollipop	Other	chewing lollipop for 10 minutes	lollipop

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
half time of gastric emptying		from drinking water to gastric volume return to half of top volume before drinking water,on an average of 2 hours

Secondary Outcomes

Measure	Description	Time Frame
time of gastric emptying		from drinking water to gastric volume return to baseline before drinking water,on an average of 2 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

volunteer aged 18 years-45 years old
volunteer with a body mass index between 18 and 28 kg/m2

Exclusion Criteria:

those with history of diabetes mellitus
those with gastric diseases
those with history of gastro-intestinal surgery
those with history of smoking
those with use of gastric mobility medicines
those with pregnancy or breeding

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Xijing Hospital		Xi'an	Shaanxi	710032	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29077816	Result	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.