Status:
COMPLETED
Response to Supplement and Placebo in GERD
Lead Sponsor:
Beth Israel Deaconess Medical Center
Conditions:
Gastroesophageal Reflux Disease (GERD)
Heartburn
Eligibility:
All Genders
18-80 years
Phase:
NA
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 wit...
Eligibility Criteria
Inclusion
- Adult humans age 18-80.
- Fluency in written and spoken English.
- Heartburn symptoms 3 or more days per week for the past month.
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01915173
Start Date
June 1 2013
End Date
April 1 2014
Last Update
March 29 2017
Active Locations (1)
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1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215