Study of a Dietary Supplement for Reflux During Sleep

NCT02274636 | Unknown

• 1 other identifier: 1401
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

GERD

Outcome Measures

Primary Outcomes (1)

• Reduction in symptoms associated with GERD

  Email questionnaire containing 9 questions of interest

  two weeks

Study Arms (2)

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.

Dietary Supplement: Xylitol

Interventions

Xylitol DIETARY_SUPPLEMENT

A comparison between discs and gel

Intervention

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Under 18
• Prior history of any of these conditions:
• coronary artery disease
• gallbladder disease
• gastric or esophageal cancer
• peptic ulcer disease
• 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

Sponsors & Collaborators

• Oral Care Research Associates, Seattle: lead

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MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Xylitol

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates

Study Officials

• Jeff A Burgess, DDS MSD

  Oral Care Research Associates, Seattle

  STUDY DIRECTOR

Central Study Contacts

Jeff A Burgess, DMD MSD

CONTACT

206 450 2640; oral.care.research.assoc@gmail.com

Peter F van der Ven, DDS PhD

CONTACT

253 874 2583; ven@seanet.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Coordinator

Study Record Dates

• First Submitted: October 22, 2014
• First Posted: October 24, 2014
• Study Start: October 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2016
• Last Updated: May 28, 2015

Record last verified: 2015-05