Study of a Dietary Supplement for Reflux During Sleep

Not Applicable

• Conditions: GERD
• Interventions: Dietary Supplement: Xylitol

• Registration Number: NCT02274636
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-10-22
• Study First Submitted QC: 2014-10-22
• Study First Posted: 2014-10-24
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-27
• Last Update Posted: 2015-05-28
• Primary Completion: 2015-10
• Study Completion: 2016-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	Xylitol	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.

Primary Outcome Measures

Name	Time	Method
Reduction in symptoms associated with GERD	two weeks	Email questionnaire containing 9 questions of interest