Clinical trial NCT01915173: Response to Supplement and Placebo in GERD
Official title: Response to Supplement and Placebo in GERD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastroesophageal Reflux Disease (GERD)
Heartburn
Dyspepsia
Keywords: Gastroesophageal reflux disease (GERD)
Heartburn
Dyspepsia
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
First posted: 2013-08-02
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: Safety - Number of Participants Experiencing a Serious Adverse Event
timeFrame: 2 week follow-up
Secondary outcomes:
measure: Number of Subjects With a 50% or Greater Decrease in GERD Symptom Severity
timeFrame: Second week of the trial compared to pre-trial baseline
measure: GERD Health-Related Quality of Life at Follow-up
timeFrame: Two weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Michelle Dossett, MD, PhD, MPH
role: STUDY_DIRECTOR
References:
citation: Dossett ML, Mu L, Davis RB, Bell IR, Lembo AJ, Kaptchuk TJ, Yeh GY. Patient-Provider Interactions Affect Symptoms in Gastroesophageal Reflux Disease: A Pilot Randomized, Double-Blind, Placebo-Controlled Trial. PLoS One. 2015 Sep 30;10(9):e0136855. doi: 10.1371/journal.pone.0136855. eCollection 2015.