GERD Clinical Trial
Official title:
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.
;
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care
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