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Study of a Dietary Supplement for Reflux During Sleep (SXDSFRS)

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ClinicalTrials.gov Identifier: NCT02274636
Recruitment Status : Unknown
Verified May 2015 by Jeff Burgess DDS MSD, Oral Care Research Associates, Seattle.
Recruitment status was:  Not yet recruiting
First Posted : October 24, 2014
Last Update Posted : May 28, 2015
Sponsor:
Information provided by (Responsible Party):
Jeff Burgess DDS MSD, Oral Care Research Associates, Seattle

Brief 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. 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.


Condition or disease Intervention/treatment Phase
GERD Dietary Supplement: Xylitol Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: Study of a Dietary Supplement for Reflux During Sleep
Study Start Date : October 2014
Estimated Primary Completion Date : October 2015
Estimated Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Xylitol

Arm Intervention/treatment
No Intervention: Data collection
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).
Active Comparator: Intervention
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.
Dietary Supplement: Xylitol
A comparison between discs and gel




Primary Outcome Measures :
  1. Reduction in symptoms associated with GERD [ Time Frame: two weeks ]
    Email questionnaire containing 9 questions of interest



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. A medical diagnosis of GERD
  2. Awakening with a taste of refluxed stomach acid in the mouth
  3. Heartburn during sleep
  4. Voice hoarseness upon awakening
  5. Antacid use at night
  6. Dry mouth at bedtime or during the night
  7. Experience difficulty chewing, swallowing, and speaking because of dry mouth

Exclusion Criteria:

  1. Under 18
  2. Prior history of any of these conditions:

    1. coronary artery disease
    2. gallbladder disease
    3. gastric or esophageal cancer
    4. peptic ulcer disease
    5. esophagitis, whether eosinophilic, infectious, or pill based
    6. esophageal motility disorders
  3. A history of thoracic, esophageal, or gastric surgery
  4. No medical examination in the prior year

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): NCT02274636


Contacts
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Contact: Jeff A Burgess, DMD MSD 206 450 2640 oral.care.research.assoc@gmail.com
Contact: Peter F van der Ven, DDS PhD 253 874 2583 ven@seanet.com

Sponsors and Collaborators
Oral Care Research Associates, Seattle
Investigators
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Study Director: Jeff A Burgess, DDS MSD Oral Care Research Associates, Seattle

Publications:
http://www.moderndentistrymedia.com/jan_feb2012/walsh.pdf; Author: LJ Walsh; Title: Clinical aspects of salivary biology for the dental clinician. In ModerDentistryMedia

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Responsible Party: Jeff Burgess DDS MSD, Research Coordinator, Oral Care Research Associates, Seattle
ClinicalTrials.gov Identifier: NCT02274636     History of Changes
Other Study ID Numbers: 1401
First Posted: October 24, 2014    Key Record Dates
Last Update Posted: May 28, 2015
Last Verified: May 2015