Response to Supplement and Placebo in GERD

Study Overview
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Brief Summary
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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.

Official Title
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Response to Supplement and Placebo in GERD

Conditions
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Heartburn, Gastroesophageal Reflux Disease (GERD), Dyspepsia

Intervention / Treatment
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* Drug: Supplement
* Drug: Placebo
* Behavioral: Expanded Interview
* Behavioral: Standard Interview


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult humans age 18-80. Fluency in written and spoken English. Heartburn symptoms 3 or more days per week for the past month. 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supplement + Expanded Interview<br>Supplement, 2 tablets sublingually 3 times a day for 2 weeks. | Drug: Supplement<br>* Abies nigra 4C, Carbo vegetabilis 4C, Nux vomica 4C, and Robinia pseudoacacia 4C<br>Behavioral: Expanded Interview<br> <br> |
| Placebo Comparator: Placebo + Standard Interview<br>Placebo, 2 tablets sublingually 3 times a day for 2 weeks. | Drug: Placebo<br>* Lactose tablets<br>Behavioral: Standard Interview<br> <br> |
| Experimental: Supplement + Standard Interview<br>Supplement, 2 tablets sublingually 3 times a day for 2 weeks. | Drug: Supplement<br>* Abies nigra 4C, Carbo vegetabilis 4C, Nux vomica 4C, and Robinia pseudoacacia 4C<br>Behavioral: Standard Interview<br> <br> |
| Placebo Comparator: Placebo + Expanded Interview<br>Placebo, 2 tablets sublingually 3 times a day for 2 weeks. | Drug: Placebo<br>* Lactose tablets<br>Behavioral: Expanded Interview<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety - Number of Participants Experiencing a Serious Adverse Event | 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. | 2 week follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects With a 50% or Greater Decrease in GERD Symptom Severity | 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. | Second week of the trial compared to pre-trial baseline | 
| GERD Health-Related Quality of Life at Follow-up | 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. | Two weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastroesophageal reflux disease (GERD), Heartburn, Dyspepsia