Response to Supplement and Placebo in GERD

Not Applicable

Completed

Interventions: Drug: Placebo
Drug: Supplement
Behavioral: Expanded Interview
Behavioral: Standard Interview

Brief Summary: The purpose of this study is to investigate the effects of a widely available over the counter supplement marketed for heartburn symptoms on symptoms and health-related quality of life in patients with gastroesophageal reflux disease (GERD). This study is designed as a pilot trial to assess safety and feasibility and to provide preliminary estimates of effect sizes.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Individuals taking a proton pump inhibitor (PPI) or H2 receptor blocker with a dose change within 2 weeks of the initial study visit.
Individuals with Crohns disease, systemic sclerosis, known active ulcer disease, gastric cancer, Barrett's esophagitis
Significant pain or difficulty with swallowing
Heavy alcohol use (defined by > 6 drinks/week for women and > 13 drinks/week for men)
Concurrent pregnancy
Dementia
Uncontrolled psychiatric disease
Individuals unable to complete a paper symptom diary for 6 of 7 days prior to their baseline visit
Subjects whose symptoms are predominantly dyspeptic more than heartburn or reflux
Subjects who have used homeopathy for GI symptoms or have received constitutional homeopathic treatment within the past 2 weeks
Subjects taking herbal products or other supplements for GERD or dyspepsia related symptoms (includes peppermint oil)
Subjects who have taken > 12 doses of NSAIDS within the prior 30 days (aspirin ≤ 325 mg daily is allowed)
Subjects with lactose intolerance

Arm && Interventions

Group	Intervention	Description
Placebo + Standard Interview	Placebo	Placebo, 2 tablets sublingually 3 times a day for 2 weeks.
Supplement + Expanded Interview	Supplement	Supplement, 2 tablets sublingually 3 times a day for 2 weeks.
Supplement + Expanded Interview	Expanded Interview	Supplement, 2 tablets sublingually 3 times a day for 2 weeks.
Supplement + Standard Interview	Supplement	Supplement, 2 tablets sublingually 3 times a day for 2 weeks.
Supplement + Standard Interview	Standard Interview	Supplement, 2 tablets sublingually 3 times a day for 2 weeks.
Placebo + Expanded Interview	Placebo	Placebo, 2 tablets sublingually 3 times a day for 2 weeks.
Placebo + Expanded Interview	Expanded Interview	Placebo, 2 tablets sublingually 3 times a day for 2 weeks.
Placebo + Standard Interview	Standard Interview	Placebo, 2 tablets sublingually 3 times a day for 2 weeks.

Primary Outcome Measures

Name	Time	Method
Safety - Number of Participants Experiencing a Serious Adverse Event	2 week follow-up	Serious adverse events (as defined by the FDA) are events that are potentially life-threatening or result in death, hospitalization, an emergency room visit, disability or permanent damage, a congenital abnormality, require intervention to prevent permanent impairment, or seriously jeopardizes a patient's health.

Secondary Outcome Measures

Name	Time	Method
Number of Subjects With a 50% or Greater Decrease in GERD Symptom Severity	Second week of the trial compared to pre-trial baseline	Average daily GERD symptom severity during the last 7 days of the study was compared to average daily GERD symptom severity at baseline using daily study diary entries. GERD symptom severity for each day was based on the sum of scores assessing the severity of daytime heartburn, nighttime heartburn, and acid reflux each on a 0-4 point scale (none, mild, moderate, severe, very severe). Higher scores signify worse symptoms. The number of subjects with a 50% or greater decrease in GERD symptom severity from baseline to end of study in each group was calculated.
GERD Health-Related Quality of Life at Follow-up	Two weeks	The GERD Health-Related Quality of Life (GERD-HRQL) scale is a validated instrument assessing GERD-specific health-related quality of life using 10 questions, each on a 0-5 point scale. Scale range is 0-50 with higher numbers signifying worse quality of life.

Locations (1): Beth Israel Deaconess Medical Center
🇺🇸
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States