Response to Supplement and Placebo in GERD
| Status: | Recruiting |
|---|---|
| Conditions: | Gastroesophageal Reflux Disease , Gastroesophageal Reflux Disease , Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 5/5/2014 |
| Start Date: | June 2013 |
| Contact: | Michelle Dossett, MD, PhD, MPH |
| Email: | mdossett@bidmc.harvard.edu |
| Phone: | 617-754-1461 |
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.
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.
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
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Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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