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Chewing Gum and Gastric Emptying of Water

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02673307
Recruitment Status : Completed
First Posted : February 3, 2016
Last Update Posted : October 14, 2016
Sponsor:
Information provided by (Responsible Party):
Lionel Bouvet, Hôpital Edouard Herriot

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

Condition or disease Intervention/treatment Phase
Comparison of Gastric Emptying Rate of Water When Chewing Gum or Not Behavioral: 1 chewing gum over 45 minutes Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Basic Science
Study Start Date : March 2016
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drinking Water

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



Primary Outcome Measures :
  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 [ Time Frame: every 20 minutes during 120 min ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • ASA 1 or 2 volunteers

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02673307


Locations
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France
Hopital Femme Mère Enfant - Hospices Civils de Lyon
Bron, France, 69500
Sponsors and Collaborators
Lionel Bouvet
Investigators
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Principal Investigator: Lionel BOUVET, MD, PhD Hospices Civils de Lyon
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Lionel Bouvet, MD, PhD, Hôpital Edouard Herriot
ClinicalTrials.gov Identifier: NCT02673307    
Other Study ID Numbers: 2016-A00009-42
L15-206 ( Other Identifier: Comité de Protection des Personnes Sud Est IV )
First Posted: February 3, 2016    Key Record Dates
Last Update Posted: October 14, 2016
Last Verified: October 2016