N/A
N=24
Response to Supplement and Placebo in GERD
Gastroesophageal Reflux Disease (GERD) · Heartburn · Dyspepsia
Bottom Line
View on ClinicalTrials.gov: NCT01915173 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcome: Primary: Safety - Number of Participants Experiencing a Serious Adverse Event — 0; 0; 0; 0 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Supplement (Drug); Placebo (Drug); Expanded Interview (Behavioral); Standard Interview (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Beth Israel Deaconess Medical Center
- Primary completion
- Apr 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety - Number of Participants Experiencing a Serious Adverse Event |
0; 0; 0; 0 | — |
| SECONDARY Number of Subjects With a 50% or Greater Decrease in GERD Symptom Severity |
2; 0; 5; 4 | 0.01 sig |
| SECONDARY GERD Health-Related Quality of Life at Follow-up |
18.2; 26.3; 17.7; 18.3 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01915173). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.