Response to Supplement and Placebo in GERD
Completed · Not applicable · Has a placebo group
Conditions studied: Gastroesophageal Reflux Disease (GERD), Heartburn, Dyspepsia
In brief
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.
Key facts
- Study ID
- NCT01915173
- Run by
- Beth Israel Deaconess Medical Center
- People needed
- 24
- Starts
- 2013-06-01
- Expected to finish
- 2014-04-01
- Last updated by the study team
- 2017-03-29
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Adult humans age 18-80.
- Fluency in written and spoken English.
- Heartburn symptoms 3 or more days per week for the past month.
You may not qualify if…
- 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
Where it is running
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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