Response to Supplement and Placebo in GERD

• Status: Completed
• Trial end date: 2014-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beth Israel Deaconess Medical Center

Criteria

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