Acute PancreatitisNCT06077188
EFFECT of CHEWING GUM on CONTROLLING NAUSEA/VOMITING and THIRST in PATIENTS with ACUTE PANCREATITIS
A study testing Gum group in people with Acute Pancreatitis and Thirst, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
Nausea and vomiting are one of the most common symptoms in acute pancreatitis. In addition to pharmacological methods for nausea and vomiting, non-pharmacological methods can also be used. Among these, anticipatory nausea and vomiting can be prevented by behaviors aimed at distracting attention. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Pancreatitis, Thirst
- What is being tested?
- Gum group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2024to 29 Jun 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Those diagnosed with acute pancreatitis,
- Without total dental prosthesis,
- Without salivary gland infection,
- Those who have not had salivary gland surgery,
- No difficulty in chewing,
- Not receiving oxygen therapy,
- Able to answer all questions and be communicativ
Who cannot join
- Those with diabetes,
- Does not like chewing gum,
- Receiving radiotherapy or chemotherapy,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Erciyes University
Nausea and vomiting are one of the most common symptoms in acute pancreatitis. In addition to pharmacological methods for nausea and vomiting, non-pharmacological methods can also be used. Among these, anticipatory nausea and vomiting can be prevented by behaviors aimed at distracting attention. This study will be conducted to evaluate the effect of chewing gum on the severity of nausea-vomiting and thirst in patients with acute pancreatitis. The study will be conducted with a total of 60 patients, 30 intervention and 30 control.
Patients in the intervention group will chew xylitol gum five times a day for three days. The patients' thirst and nausea and vomiting conditions will be examined.
- Conditions
- Acute Pancreatitis, Thirst
- Being tested
- Gum group
- Keywords
- Acute Pancreatitis, Thirst, nouse, vomiting
- Medical subject headings
- Pancreatitis, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gum groupOther
Group chewing gum with xylitol
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | Not described Receives: Other: Gum group |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thirst Severity -Visual Analog Scale
Visual Analog Scale is a 10 cm long scale that evaluates the severity of thirst.
Measured: Apply in the morning of the 1st day after application
Secondary outcomes (2)
Rhodes Nausea, Vomiting and Retching Index
It is an eight-item scale that measures the number and severity of patients' nausea, vomiting and retching in the last 24 hours.
Measured: Apply in the morning of the 1st day after application
Rhodes Nausea, Vomiting and Retching Index (
It is an eight-item scale that measures the number and severity of patients' nausea, vomiting and retching in the last 24 hours.
Measured: Apply in the morning of the 1st day after application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2023
- Study start15 Mar 2024
- Primary completion1 May 2024
- Study completion29 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Acute PancreatitisStudies of the same condition, open and under way.
- More trials run by TC Erciyes UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Özlem Ceyhan, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06077188
- Sponsor's protocol ID
- Thirstgum
- Status last verified
- Feb 2024
- First submitted
- 5 Oct 2023
- Last updated
- 3 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jensdottir T, Buchwald C, Nauntofte B, Hansen HS, Bardow A. Saliva in relation to dental erosion before and after radiotherapy. Acta Odontol Scand. 2013 May-Jul;71(3-4):1008-13. doi: 10.3109/00016357.2012.741704. Epub 2012 Nov 21.
PubMed 23167908Oyetola EO, Owotade FJ, Agbelusi GA, Fatusi OA, Sanusi AA. Oral findings in chronic kidney disease: implications for management in developing countries. BMC Oral Health. 2015 Feb 20;15:24. doi: 10.1186/s12903-015-0004-z.
PubMed 25888327Silva AC, Aprile LR, Dantas RO. EFFECT OF GUM CHEWING ON AIR SWALLOWING, SALIVA SWALLOWING AND BELCHING. Arq Gastroenterol. 2015 Jul-Sep;52(3):190-4. doi: 10.1590/S0004-28032015000300007.
PubMed 26486285Honarmand M, Farhad-Mollashahi L, Nakhaee A, Sargolzaie F. Oral manifestation and salivary changes in renal patients undergoing hemodialysis. J Clin Exp Dent. 2017 Feb 1;9(2):e207-e210. doi: 10.4317/jced.53215. eCollection 2017 Feb.
PubMed 28210437
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Erciyes University
- ClinicalTrials.gov ID
- NCT06077188
- Acronym / sponsor ID
- Thirstgum
- Conditions
- Acute Pancreatitis, Thirst
- Keywords
- Acute Pancreatitis, Thirst, nouse, vomiting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 15 Mar 2024 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 29 Jun 2024 (actual)
- First posted
- 11 Oct 2023 (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.
Nausea and vomiting are one of the most common symptoms in acute pancreatitis. In addition to pharmacological methods for nausea and vomiting, non-pharmacological methods can also be used. Among these, anticipatory nausea and vomiting can be prevented by behaviors aimed at distracting attention. This study will be conducted to evaluate the effect of chewing gum on the severity of nausea-vomiting and thirst in patients with acute pancreatitis. The study will be conducted with a total of 60 patients, 30 intervention and 30 control.
Patients in the intervention group will chew xylitol gum five times a day for three days. The patients' thirst and nausea and vomiting conditions will be examined.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Other: Gum group |
| Control group | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Those diagnosed with acute pancreatitis,
Key exclusion criteria (3 listed)
- Those with diabetes,
- Does not like chewing gum,
- Receiving radiotherapy or chemotherapy,
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 |
|---|---|---|
| Gum groupGroup chewing gum with xylitol | Other | intervention group |
Primary outcome
Thirst Severity -Visual Analog Scale
Time frame: Apply in the morning of the 1st day after application
Visual Analog Scale is a 10 cm long scale that evaluates the severity of thirst.
2 secondary outcomes
Rhodes Nausea, Vomiting and Retching Index
Time frame: Apply in the morning of the 1st day after application
Rhodes Nausea, Vomiting and Retching Index (
Time frame: Apply in the morning of the 1st day after application
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 3 Mar 2025.
- Background: PubMed 23167908Jensdottir T, Buchwald C, Nauntofte B, Hansen HS, Bardow A. Saliva in relation to dental erosion before and after radiotherapy. Acta Odontol Scand. 2013 May-Jul;71(3-4):1008-13. doi: 10.3109/00016357.2012.741704. Epub 2012 Nov 21.
- Background: PubMed 25888327Oyetola EO, Owotade FJ, Agbelusi GA, Fatusi OA, Sanusi AA. Oral findings in chronic kidney disease: implications for management in developing countries. BMC Oral Health. 2015 Feb 20;15:24. doi: 10.1186/s12903-015-0004-z.
- Background: PubMed 26486285Silva AC, Aprile LR, Dantas RO. EFFECT OF GUM CHEWING ON AIR SWALLOWING, SALIVA SWALLOWING AND BELCHING. Arq Gastroenterol. 2015 Jul-Sep;52(3):190-4. doi: 10.1590/S0004-28032015000300007.
- Background: PubMed 28210437Honarmand M, Farhad-Mollashahi L, Nakhaee A, Sargolzaie F. Oral manifestation and salivary changes in renal patients undergoing hemodialysis. J Clin Exp Dent. 2017 Feb 1;9(2):e207-e210. doi: 10.4317/jced.53215. eCollection 2017 Feb.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 group in people with Acute Pancreatitis and Thirst, run by TC Erciyes University 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 7 inclusion and 3 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 3 Mar 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?
Thirst Severity -Visual Analog Scale (time frame: Apply in the morning of the 1st day after application). 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 NCT06077188, which also lists 4 linked publications.
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 3 Mar 2025.