Comparison of Gastric Emptying Rate of Water When Chewing Gum or NotNCT02673307
Chewing Gum and Gastric Emptying of Water
A study testing 1 chewing gum over 45 minutes in people with Comparison of Gastric Emptying Rate of Water When Chewing Gum or Not, run by Lionel Bouvet at 1 site in France.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Comparison of Gastric Emptying Rate of Water When Chewing Gum or Not
- What is being tested?
- 1 chewing gum over 45 minutes
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2016to Oct 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ASA 1 or 2 volunteers
Who cannot join
- digestive diseases, gastroparesis
- Smokers
- Pregnancy
- Diabetes Mellitus
- Medication affecting gastric motility
- Previous gastrointestinal surgery
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- 1 chewing gum over 45 minutes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1 chewing gum over 45 minutesBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: 1 chewing gum over 45 minutes |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: every 20 minutes during 120 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2016 (estimated)
- Study startMar 2016
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Comparison of Gastric Emptying Rate of Water When Chewing Gum or NotStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lionel Bouvet
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lionel Bouvet, Hôpital Edouard Herriot
- Investigators
- Lionel BOUVET, MD, PhD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02673307
- Sponsor's protocol ID
- 2016-A00009-42
- Other IDs
- L15-206
- Status last verified
- Oct 2016
- First submitted
- 1 Feb 2016
- Last updated
- 14 Oct 2016
- Results posted
- No
Publications
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.
PubMed 29077816
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chewing Gum and Gastric Emptying of Water
- ClinicalTrials.gov ID
- NCT02673307
- Acronym / sponsor ID
- 2016-A00009-42
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Lionel BouvetUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 3 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Controle | No intervention | –The volunteer does not chew gum during the study period |
| Chewing gum | Experimental | Behavioral: 1 chewing gum over 45 minutesThe volunteer chews gum during the first 45 min after ingestion of 250 ml water |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ASA 1 or 2 volunteers
Key exclusion criteria (6 listed)
- digestive diseases, gastroparesis
- Smokers
- Pregnancy
- Diabetes Mellitus
- Medication affecting gastric motility
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1 chewing gum over 45 minutes | Behavioural | Chewing gum |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2016.
- Derived from this study: PubMed 29077816Bouvet 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lionel BOUVET, MD, PhD principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1 chewing gum over 45 minutes in people with Comparison of Gastric Emptying Rate of Water When Chewing Gum or Not, run by Lionel Bouvet at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02673307, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2016.