GERDSXDSFRSNCT02274636
Study of a Dietary Supplement for Reflux During Sleep
A study testing Xylitol in people with GERD, run by Oral Care Research Associates, Seattle.
Trial summary
This research study is a randomized, controlled study developed to test how well a dry mouth product that contains xylitol affects some of the symptoms of gastroesophageal reflux disease (GERD. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- GERD
- What is being tested?
- Xylitol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Oct 2014to 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- A medical diagnosis of GERD
- Awakening with a taste of refluxed stomach acid in the mouth
- Heartburn during sleep
- Voice hoarseness upon awakening
- Antacid use at night
- Dry mouth at bedtime or during the night
- Experience difficulty chewing, swallowing, and speaking because of dry mouth
Who cannot join
- Under 18
- Prior history of any of these conditions:
- coronary artery disease
- gallbladder disease
- gastric or esophageal cancer
- peptic ulcer disease
Show all 10Show fewer
- esophagitis, whether eosinophilic, infectious, or pill based
- esophageal motility disorders
- A history of thoracic, esophageal, or gastric surgery
- No medical examination in the prior year
Trial locations and contacts
No sites are listed yet.
About this study
This research study is a randomized, controlled study developed to test how well a dry mouth product that contains xylitol affects some of the symptoms of gastroesophageal reflux disease (GERD. Individuals who experience symptoms of gastro esophageal reflux disease (GERD) and who are accepted into the study will be asked to report on the frequency and severity of several symptoms specific to the condition that occur during sleep. The study is composed of two phases:
Phase one involves collection of baseline information for two weeks. Phase two is the intervention phase of the study. In this phase of the study, each subject will be randomly assigned (like flipping a coin) to use either "the product" of interest or a different dry mouth product for two weeks.
Read the detailed description
The study is composed of two phases:
Phase one involves collection of baseline information for two weeks. Phase two is the intervention phase of the study. In this phase of the study, each subject will be randomly assigned (like flipping a coin) to use either "the product" of interest or a different dry mouth product for two weeks.
Phase 1
This first phase will involve having you report to the research coordinator through email the presence or absence of several symptoms associated with GERD that can occur during sleep. Phase 1 will occur over 14 days (and nights). You will also be asked to rate the relative severity of some of the symptoms. The information collected during this initial phase of the study will then be used to establish baseline values for the symptoms of interest and determine your eligibility for the intervention phase (phase 2) of the study.
Phase 2
In the second phase of the study, you will be given either enough gel or enough discs to use for 14 days (the duration of the second phase of the study). If you are given the gel, a small amount (specified in the directions) is to be applied to the mouth lining just before bed. If you are given the discs, one will be placed on the gums beside a molar in each cheek each night just before bed (specified in the directions). You will be asked to continue to provide daily email communication with the research coordinator detailing symptoms suggesting reflux experienced the prior night during product use as you did during phase 1 of the study.
During phases 1 and 2 of the study, you will be asked to continue taking any previously prescribed medication or over-the-counter preparations that you normally take for reflux and to maintain your regular dietary habits. However, you should not take any dry mouth remedy other than those supplied by the research coordinator just before bed.
- Conditions
- GERD
- Being tested
- Xylitol
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XylitolDietary supplement
A comparison between discs and gel
| Study group | Role | What they receive |
|---|---|---|
| Data collection | No intervention | This first phase will involve having you report to the research coordinator through email the presence or absence of several symptoms associated with GERD that can occur during sleep. Phase 1 will occur over 14 days (and nights). |
| Intervention | Active comparator | In the second phase of the study, each subject will be given either a gel containing xylitol or discs containing xylitol to use for 14 days (the duration of the second phase of the study). If given the gel, a small amount (specified in the directions) is to be applied to the mouth lining just before bed. If given the discs, one will be placed on the gums beside a molar in each cheek each night just before bed (specified in the directions). Each subject will be asked to continue to provide daily email communication with the research coordinator detailing symptoms suggesting reflux experienced the prior night during product use as was provided during phase 1 of the study. Receives: Dietary Supplement: Xylitol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in symptoms associated with GERD
Email questionnaire containing 9 questions of interest
Measured: two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionOct 2015 (estimated)
- Study completionOct 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (45)Papers the sponsor has linked to this study.
- Other trials for GERDStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oral Care Research Associates, Seattle
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeff Burgess DDS MSD, Oral Care Research Associates, Seattle
- Investigators
- Jeff A Burgess, DDS MSD, Study director, Oral Care Research Associates, Seattle
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02274636
- Sponsor's protocol ID
- 1401
- Acronym
- SXDSFRS
- Status last verified
- May 2015
- First submitted
- 22 Oct 2014
- Last updated
- 28 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Holtmann G. Reflux disease: the disorder of the third millennium. Eur J Gastroenterol Hepatol. 2001 May;13 Suppl 1:S5-11.
PubMed 11430509Jung HK, Choung RS, Talley NJ. Gastroesophageal reflux disease and sleep disorders: evidence for a causal link and therapeutic implications. J Neurogastroenterol Motil. 2010 Jan;16(1):22-9. doi: 10.5056/jnm.2010.16.1.22. Epub 2010 Jan 31.
PubMed 20535322Ranjitkar S, Smales RJ, Kaidonis JA. Oral manifestations of gastroesophageal reflux disease. J Gastroenterol Hepatol. 2012 Jan;27(1):21-7. doi: 10.1111/j.1440-1746.2011.06945.x.
PubMed 22004279Bardhan KD, Strugala V, Dettmar PW. Reflux revisited: advancing the role of pepsin. Int J Otolaryngol. 2012;2012:646901. doi: 10.1155/2012/646901. Epub 2011 Nov 10.
PubMed 22242022Fass R, Pulliam G, Johnson C, Garewal HS, Sampliner RE. Symptom severity and oesophageal chemosensitivity to acid in older and young patients with gastro-oesophageal reflux. Age Ageing. 2000 Mar;29(2):125-30. doi: 10.1093/ageing/29.2.125.
PubMed 10791446Chait MM. Gastroesophageal reflux disease: Important considerations for the older patients. World J Gastrointest Endosc. 2010 Dec 16;2(12):388-96. doi: 10.4253/wjge.v2.i12.388.
PubMed 21191512Saritas Yuksel E, Vaezi MF. New developments in extraesophageal reflux disease. Gastroenterol Hepatol (N Y). 2012 Sep;8(9):590-9.
PubMed 23483833DeVault KR, Castell DO; American College of Gastroenterology. Updated guidelines for the diagnosis and treatment of gastroesophageal reflux disease. Am J Gastroenterol. 2005 Jan;100(1):190-200. doi: 10.1111/j.1572-0241.2005.41217.x.
PubMed 15654800Kahrilas PJ, Shaheen NJ, Vaezi MF, Hiltz SW, Black E, Modlin IM, Johnson SP, Allen J, Brill JV; American Gastroenterological Association. American Gastroenterological Association Medical Position Statement on the management of gastroesophageal reflux disease. Gastroenterology. 2008 Oct;135(4):1383-1391, 1391.e1-5. doi: 10.1053/j.gastro.2008.08.045. No abstract available.
PubMed 18789939Dolder M, Tutuian R. Laboratory based investigations for diagnosing gastroesophageal reflux disease. Best Pract Res Clin Gastroenterol. 2010 Dec;24(6):787-98. doi: 10.1016/j.bpg.2010.10.005.
PubMed 21126694Katz PO, Gerson LB, Vela MF. Guidelines for the diagnosis and management of gastroesophageal reflux disease. Am J Gastroenterol. 2013 Mar;108(3):308-28; quiz 329. doi: 10.1038/ajg.2012.444. Epub 2013 Feb 19. No abstract available.
PubMed 23419381Locke GR 3rd, Talley NJ, Fett SL, Zinsmeister AR, Melton LJ 3rd. Prevalence and clinical spectrum of gastroesophageal reflux: a population-based study in Olmsted County, Minnesota. Gastroenterology. 1997 May;112(5):1448-56. doi: 10.1016/s0016-5085(97)70025-8.
PubMed 9136821Fass R, Achem SR, Harding S, Mittal RK, Quigley E. Review article: supra-oesophageal manifestations of gastro-oesophageal reflux disease and the role of night-time gastro-oesophageal reflux. Aliment Pharmacol Ther. 2004 Dec;20 Suppl 9:26-38. doi: 10.1111/j.1365-2036.2004.02253.x.
PubMed 15527462Eckley CA, Rios Lda S, Rizzo LV. Salivary egf concentration in adults with reflux chronic laryngitis before and after treatment: preliminary results. Braz J Otorhinolaryngol. 2007 Mar-Apr;73(2):156-60. doi: 10.1016/s1808-8694(15)31060-0.
PubMed 17589721Guare RO, Ferreira MC, Leite MF, Rodrigues JA, Lussi A, Santos MT. Dental erosion and salivary flow rate in cerebral palsy individuals with gastroesophageal reflux. J Oral Pathol Med. 2012 May;41(5):367-71. doi: 10.1111/j.1600-0714.2011.01112.x. Epub 2011 Nov 14.
PubMed 22077728
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of a Dietary Supplement for Reflux During Sleep
- ClinicalTrials.gov ID
- NCT02274636
- Acronym / sponsor ID
- SXDSFRS / 1401
- Conditions
- GERD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Oral Care Research Associates, SeattleUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Oct 2015 (estimated)
- Study completion
- Oct 2016 (estimated)
- First posted
- 24 Oct 2014 (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.
This research study is a randomized, controlled study developed to test how well a dry mouth product that contains xylitol affects some of the symptoms of gastroesophageal reflux disease (GERD. Individuals who experience symptoms of gastro esophageal reflux disease (GERD) and who are accepted into the study will be asked to report on the frequency and severity of several symptoms specific to the condition that occur during sleep. The study is composed of two phases:
Phase one involves collection of baseline information for two weeks. Phase two is the intervention phase of the study. In this phase of the study, each subject will be randomly assigned (like flipping a coin) to use either "the product" of interest or a different dry mouth product for two weeks.
Detailed description
The study is composed of two phases:
Phase one involves collection of baseline information for two weeks. Phase two is the intervention phase of the study. In this phase of the study, each subject will be randomly assigned (like flipping a coin) to use either "the product" of interest or a different dry mouth product for two weeks.
Phase 1
This first phase will involve having you report to the research coordinator through email the presence or absence of several symptoms associated with GERD that can occur during sleep. Phase 1 will occur over 14 days (and nights). You will also be asked to rate the relative severity of some of the symptoms. The information collected during this initial phase of the study will then be used to establish baseline values for the symptoms of interest and determine your eligibility for the intervention phase (phase 2) of the study.
Phase 2
In the second phase of the study, you will be given either enough gel or enough discs to use for 14 days (the duration of the second phase of the study). If you are given the gel, a small amount (specified in the directions) is to be applied to the mouth lining just before bed. If you are given the discs, one will be placed on the gums beside a molar in each cheek each night just before bed (specified in the directions). You will be asked to continue to provide daily email communication with the research coordinator detailing symptoms suggesting reflux experienced the prior night during product use as you did during phase 1 of the study.
During phases 1 and 2 of the study, you will be asked to continue taking any previously prescribed medication or over-the-counter preparations that you normally take for reflux and to maintain your regular dietary habits. However, you should not take any dry mouth remedy other than those supplied by the research coordinator just before bed.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Data collection | No intervention | –This first phase will involve having you report to the research coordinator through email the presence or absence of several symptoms associated with GERD that can occur during sleep. Phase 1 will occur over 14 days (and nights). |
| Intervention | Active comparator | Dietary Supplement: XylitolIn the second phase of the study, each subject will be given either a gel containing xylitol or discs containing xylitol to use for 14 days (the duration of the second phase of the study). If given the gel, a small amount (specified in the directions) is to be applied to the mouth lining just before bed. If given the discs, one will be placed on the gums beside a molar in each cheek each night just before bed (specified in the directions). Each subject will be asked to continue to provide daily email communication with the research coordinator detailing symptoms suggesting reflux experienced the prior night during product use as was provided during phase 1 of the study. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- A medical diagnosis of GERD
- Awakening with a taste of refluxed stomach acid in the mouth
- Heartburn during sleep
- Voice hoarseness upon awakening
- Antacid use at night
Key exclusion criteria (10 listed)
- Under 18
- Prior history of any of these conditions:
- A history of thoracic, esophageal, or gastric surgery
- No medical examination in the prior year
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 |
|---|---|---|
| XylitolA comparison between discs and gel | Dietary supplement | Intervention |
Primary outcome
Reduction in symptoms associated with GERD
Time frame: two weeks
Email questionnaire containing 9 questions of interest
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2015.
- Background: PubMed 11430509Holtmann G. Reflux disease: the disorder of the third millennium. Eur J Gastroenterol Hepatol. 2001 May;13 Suppl 1:S5-11.
- Background: PubMed 20535322Jung HK, Choung RS, Talley NJ. Gastroesophageal reflux disease and sleep disorders: evidence for a causal link and therapeutic implications. J Neurogastroenterol Motil. 2010 Jan;16(1):22-9. doi: 10.5056/jnm.2010.16.1.22. Epub 2010 Jan 31.
- Background: PubMed 22004279Ranjitkar S, Smales RJ, Kaidonis JA. Oral manifestations of gastroesophageal reflux disease. J Gastroenterol Hepatol. 2012 Jan;27(1):21-7. doi: 10.1111/j.1440-1746.2011.06945.x.
- Background: PubMed 22242022Bardhan KD, Strugala V, Dettmar PW. Reflux revisited: advancing the role of pepsin. Int J Otolaryngol. 2012;2012:646901. doi: 10.1155/2012/646901. Epub 2011 Nov 10.
- Background: PubMed 10791446Fass R, Pulliam G, Johnson C, Garewal HS, Sampliner RE. Symptom severity and oesophageal chemosensitivity to acid in older and young patients with gastro-oesophageal reflux. Age Ageing. 2000 Mar;29(2):125-30. doi: 10.1093/ageing/29.2.125.
- Background: PubMed 21191512Chait MM. Gastroesophageal reflux disease: Important considerations for the older patients. World J Gastrointest Endosc. 2010 Dec 16;2(12):388-96. doi: 10.4253/wjge.v2.i12.388.
- Background: PubMed 23483833Saritas Yuksel E, Vaezi MF. New developments in extraesophageal reflux disease. Gastroenterol Hepatol (N Y). 2012 Sep;8(9):590-9.
- Background: PubMed 15654800DeVault KR, Castell DO; American College of Gastroenterology. Updated guidelines for the diagnosis and treatment of gastroesophageal reflux disease. Am J Gastroenterol. 2005 Jan;100(1):190-200. doi: 10.1111/j.1572-0241.2005.41217.x.
- Background: PubMed 18789939Kahrilas PJ, Shaheen NJ, Vaezi MF, Hiltz SW, Black E, Modlin IM, Johnson SP, Allen J, Brill JV; American Gastroenterological Association. American Gastroenterological Association Medical Position Statement on the management of gastroesophageal reflux disease. Gastroenterology. 2008 Oct;135(4):1383-1391, 1391.e1-5. doi: 10.1053/j.gastro.2008.08.045. No abstract available.
- Background: PubMed 21126694Dolder M, Tutuian R. Laboratory based investigations for diagnosing gastroesophageal reflux disease. Best Pract Res Clin Gastroenterol. 2010 Dec;24(6):787-98. doi: 10.1016/j.bpg.2010.10.005.
- Background: PubMed 23419381Katz PO, Gerson LB, Vela MF. Guidelines for the diagnosis and management of gastroesophageal reflux disease. Am J Gastroenterol. 2013 Mar;108(3):308-28; quiz 329. doi: 10.1038/ajg.2012.444. Epub 2013 Feb 19. No abstract available.
- Background: PubMed 9136821Locke GR 3rd, Talley NJ, Fett SL, Zinsmeister AR, Melton LJ 3rd. Prevalence and clinical spectrum of gastroesophageal reflux: a population-based study in Olmsted County, Minnesota. Gastroenterology. 1997 May;112(5):1448-56. doi: 10.1016/s0016-5085(97)70025-8.
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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.
Jeff A Burgess, DDS MSD study director
Oral Care Research Associates, Seattle
Questions about this trial
What is this clinical trial studying?
A study testing Xylitol in people with GERD, run by Oral Care Research Associates, Seattle.
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 10 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: status not confirmed, as of the sponsor's last update on 28 May 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jeff A Burgess, DMD MSD (206 450 2640, oral.care.research.assoc@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in symptoms associated with GERD (time frame: two weeks). 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 NCT02274636, which also lists 45 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 28 May 2015.