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

Use our guide to learn which trials are right for you!

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.


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
We found this trial at
1
site
330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
?
mi
from
Boston, MA
Click here to add this to my saved trials