GastroscopyNCT06842602
Evaluation of Gastric Volume and pH Changes in Gastroscopy Patients
A study testing gum, candy and strict fasting rules in people with Gastroscopy, run by Bursa Yuksek Ihtisas Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Pulmonary aspiration is a rare but serious complication that can result in 57% mortality and 14% permanent damage. Fasting rules (solid foods 6-8 hours, clear liquids 2 hours) determined by anesthesia associations are applied to prevent pulmonary aspiration by reducing gastric volume. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gastroscopy
- What is being tested?
- gum, candy and strict fasting rules
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 405 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2023to 1 Jan 2024
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I-III,
- oriented
- cooperative
- scheduled for elective gastroscopy
Who cannot join
- body mass index is (BMI) >30 kg/m2,
- full stomach predicted patients (obstruction, stenosis, bleeding, ascites, urgency),
- patients with diabetes
- patients with who underwent bowel cleansing
- patients who did not want to give consent to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Gastric Volume and pH Changes in Gastroscopy Patients Using Chewing Gum and Candy: Prospective Randomized Double-Blind Study
Pulmonary aspiration is a rare but serious complication that can result in 57% mortality and 14% permanent damage. Fasting rules (solid foods 6-8 hours, clear liquids 2 hours) determined by anesthesia associations are applied to prevent pulmonary aspiration by reducing gastric volume. Gastric volume (≥ 0.5 mL/kg) and pH (<2.5) values are shown to be determinants in the occurrence of pulmonary complications .
Read the detailed description
The hypothesis of this study was that preprocedure candy and chewing gum use may have no effects on gastric residual volume and pH. For this purpose, we analyzed the gastric residual volume and gastric pH values of patients who were given gum and candy before the procedure.
- Conditions
- Gastroscopy
- Being tested
- gum, candy, strict fasting rules
- Keywords
- gastric pH, gastric residual volume, gastroscopy, candy, gum, preoperative fasting rules
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gumOther
chewed gum within 2 hours before the procedure
candyOther
consumed candy within 2 hours before the procedure
strict fasting rulesOther
followed strict fasting rules
| Study group | Role | What they receive |
|---|---|---|
| Group control | Active comparator | strict fasting rules Receives: Other: strict fasting rules |
| Group gum | Active comparator | chewed gum within 2 hours before the procedure Receives: Other: gum |
| Group candy | Active comparator | consumed candy within 2 hours before the procedure Receives: Other: candy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastric volume
No washing was performed during the insertion and advancement of the endoscope. The entire gastric volume were aspirated into a scaled container (medbar collection container). The amount of collected samples was recorded .
Measured: baseline
Gastric pH measurements
No washing was performed during the insertion and advancement of the endoscope. The entire gastric contents were aspirated into a scaled container (medbar collection container). The amount of collected samples was recorded and pH analysis (WTW inoLab® pH 7310 Table Type pH Meter) was performed.
Measured: baseline
Secondary outcomes (3)
endoscopist satisfaction
At the end of the procedure, endoscopist satisfaction (0=unsatisfied 1=abstained 2=satisfied) and procedure difficulty (0=easy 1=normal 2=difficult)
Measured: baseline
general procedure satisfaction
Before discharge, general procedure satisfaction (0=unsatisfied, 1=abstained, 2=satisfied), product satisfaction (0=unsatisfied, 1=abstained, 2=satisfied), product effects (1=increase in hunger, 2=increase in thirst, 3=increase in dyspepsia, 4=abstained, 5= decrease in hunger, 6= decrease in thirst, 7= decrease in dyspepsia)
Measured: baseline
Complication
Measured: Perioperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2025
- Study start1 Jan 2023
- Primary completion1 Aug 2023
- Study completion1 Jan 2024
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 GastroscopyStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 405 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mehmet Fatih Erol, Bursa Yuksek Ihtisas Training and Research Hospital
- Investigators
- Mehmet fatih erol, M.D, Study director, Bursa Yuksek ıhtısas traFüsun gözen, M.D, Study director, Bursa Yuksek Ihtısas tranin and research hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06842602
- Sponsor's protocol ID
- 2023/07-11
- Status last verified
- Apr 2025
- First submitted
- 19 Feb 2025
- Last updated
- 15 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gozen F, Erol MF. Evaluation of gastric volume and pH changes in gastroscopy patients using chewing gum and candy: A prospective randomized double-blind study. Medicine (Baltimore). 2026 Jul 10;105(28):e49731. doi: 10.1097/MD.0000000000049731.
PubMed 42432944
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Gastric Volume and pH Changes in Gastroscopy Patients Using Chewing Gum and Candy: Prospective Randomized Double-Blind Study
- ClinicalTrials.gov ID
- NCT06842602
- Acronym / sponsor ID
- 2023/07-11
- Conditions
- Gastroscopy
- Keywords
- gastric pH, gastric residual volume, gastroscopy, candy, gum, preoperative fasting rules
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 405 participants (actual)
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research HospitalOther government
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 24 Feb 2025 (actual)
- 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.
Pulmonary aspiration is a rare but serious complication that can result in 57% mortality and 14% permanent damage. Fasting rules (solid foods 6-8 hours, clear liquids 2 hours) determined by anesthesia associations are applied to prevent pulmonary aspiration by reducing gastric volume. Gastric volume (≥ 0.5 mL/kg) and pH (<2.5) values are shown to be determinants in the occurrence of pulmonary complications .
Detailed description
The hypothesis of this study was that preprocedure candy and chewing gum use may have no effects on gastric residual volume and pH. For this purpose, we analyzed the gastric residual volume and gastric pH values of patients who were given gum and candy before the procedure.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group control | Active comparator | Other: strict fasting rulesstrict fasting rules |
| Group gum | Active comparator | Other: gumchewed gum within 2 hours before the procedure |
| Group candy | Active comparator | Other: candyconsumed candy within 2 hours before the procedure |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ASA I-III,
- oriented
- cooperative
- scheduled for elective gastroscopy
Key exclusion criteria (5 listed)
- body mass index is (BMI) >30 kg/m2,
- full stomach predicted patients (obstruction, stenosis, bleeding, ascites, urgency),
- patients with diabetes
- patients with who underwent bowel cleansing
- patients who did not want to give consent to participate
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 |
|---|---|---|
| gumchewed gum within 2 hours before the procedure | Other | Group gum |
| candyconsumed candy within 2 hours before the procedure | Other | Group candy |
| strict fasting rulesfollowed strict fasting rules | Other | Group control |
Primary outcome
Gastric volume
Time frame: baseline
No washing was performed during the insertion and advancement of the endoscope. The entire gastric volume were aspirated into a scaled container (medbar collection container). The amount of collected samples was recorded .
Gastric pH measurements
Time frame: baseline
No washing was performed during the insertion and advancement of the endoscope. The entire gastric contents were aspirated into a scaled container (medbar collection container). The amount of collected samples was recorded and pH analysis (WTW inoLab® pH 7310 Table Type pH Meter) was performed.
3 secondary outcomes
endoscopist satisfaction
Time frame: baseline
general procedure satisfaction
Time frame: baseline
Complication
Time frame: Perioperative
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 15 Apr 2025.
- Derived from this study: PubMed 42432944Gozen F, Erol MF. Evaluation of gastric volume and pH changes in gastroscopy patients using chewing gum and candy: A prospective randomized double-blind study. Medicine (Baltimore). 2026 Jul 10;105(28):e49731. doi: 10.1097/MD.0000000000049731.
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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.
Mehmet fatih erol, M.D study director
Bursa Yuksek ıhtısas tra
Füsun gözen, M.D study director
Bursa Yuksek Ihtısas tranin and research hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing gum, candy and strict fasting rules in people with Gastroscopy, run by Bursa Yuksek Ihtisas Training and Research Hospital at 1 site in Turkey (Türkiye).
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 4 inclusion and 5 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 15 Apr 2025. 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 Turkey (Türkiye). 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?
Gastric volume (time frame: baseline). The study lists 2 primary outcomes in all. 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 NCT06842602, 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 15 Apr 2025.