Study of a Dietary Supplement for Reflux During Sleep
Study of a Dietary Supplement for Reflux During Sleep
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.
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.
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