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Response to Supplement and Placebo in GERD

Primary Purpose

Gastroesophageal Reflux Disease (GERD), Heartburn, Dyspepsia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Supplement
Placebo
Expanded Interview
Standard Interview
Sponsored by
Beth Israel Deaconess Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastroesophageal Reflux Disease (GERD) focused on measuring Gastroesophageal reflux disease (GERD), Heartburn, Dyspepsia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Beth Israel Deaconess Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

Supplement + Expanded Interview

Placebo + Standard Interview

Supplement + Standard Interview

Placebo + Expanded Interview

Arm Description

Supplement, 2 tablets sublingually 3 times a day for 2 weeks.

Placebo, 2 tablets sublingually 3 times a day for 2 weeks.

Supplement, 2 tablets sublingually 3 times a day for 2 weeks.

Placebo, 2 tablets sublingually 3 times a day for 2 weeks.

Outcomes

Primary Outcome Measures

Safety - Number of Participants Experiencing a Serious Adverse Event
Serious adverse events (as defined by the FDA) are events that are potentially life-threatening or result in death, hospitalization, an emergency room visit, disability or permanent damage, a congenital abnormality, require intervention to prevent permanent impairment, or seriously jeopardizes a patient's health.

Secondary Outcome Measures

Number of Subjects With a 50% or Greater Decrease in GERD Symptom Severity
Average daily GERD symptom severity during the last 7 days of the study was compared to average daily GERD symptom severity at baseline using daily study diary entries. GERD symptom severity for each day was based on the sum of scores assessing the severity of daytime heartburn, nighttime heartburn, and acid reflux each on a 0-4 point scale (none, mild, moderate, severe, very severe). Higher scores signify worse symptoms. The number of subjects with a 50% or greater decrease in GERD symptom severity from baseline to end of study in each group was calculated.
GERD Health-Related Quality of Life at Follow-up
The GERD Health-Related Quality of Life (GERD-HRQL) scale is a validated instrument assessing GERD-specific health-related quality of life using 10 questions, each on a 0-5 point scale. Scale range is 0-50 with higher numbers signifying worse quality of life.

Full Information

First Posted
July 30, 2013
Last Updated
February 24, 2017
Sponsor
Beth Israel Deaconess Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01915173
Brief Title
Response to Supplement and Placebo in GERD
Official Title
Response to Supplement and Placebo in GERD
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beth Israel Deaconess Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux Disease (GERD), Heartburn, Dyspepsia
Keywords
Gastroesophageal reflux disease (GERD), Heartburn, Dyspepsia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Supplement + Expanded Interview
Arm Type
Experimental
Arm Description
Supplement, 2 tablets sublingually 3 times a day for 2 weeks.
Arm Title
Placebo + Standard Interview
Arm Type
Placebo Comparator
Arm Description
Placebo, 2 tablets sublingually 3 times a day for 2 weeks.
Arm Title
Supplement + Standard Interview
Arm Type
Experimental
Arm Description
Supplement, 2 tablets sublingually 3 times a day for 2 weeks.
Arm Title
Placebo + Expanded Interview
Arm Type
Placebo Comparator
Arm Description
Placebo, 2 tablets sublingually 3 times a day for 2 weeks.
Intervention Type
Drug
Intervention Name(s)
Supplement
Intervention Description
Abies nigra 4C, Carbo vegetabilis 4C, Nux vomica 4C, and Robinia pseudoacacia 4C
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Lactose tablets
Intervention Type
Behavioral
Intervention Name(s)
Expanded Interview
Intervention Type
Behavioral
Intervention Name(s)
Standard Interview
Primary Outcome Measure Information:
Title
Safety - Number of Participants Experiencing a Serious Adverse Event
Description
Serious adverse events (as defined by the FDA) are events that are potentially life-threatening or result in death, hospitalization, an emergency room visit, disability or permanent damage, a congenital abnormality, require intervention to prevent permanent impairment, or seriously jeopardizes a patient's health.
Time Frame
2 week follow-up
Secondary Outcome Measure Information:
Title
Number of Subjects With a 50% or Greater Decrease in GERD Symptom Severity
Description
Average daily GERD symptom severity during the last 7 days of the study was compared to average daily GERD symptom severity at baseline using daily study diary entries. GERD symptom severity for each day was based on the sum of scores assessing the severity of daytime heartburn, nighttime heartburn, and acid reflux each on a 0-4 point scale (none, mild, moderate, severe, very severe). Higher scores signify worse symptoms. The number of subjects with a 50% or greater decrease in GERD symptom severity from baseline to end of study in each group was calculated.
Time Frame
Second week of the trial compared to pre-trial baseline
Title
GERD Health-Related Quality of Life at Follow-up
Description
The GERD Health-Related Quality of Life (GERD-HRQL) scale is a validated instrument assessing GERD-specific health-related quality of life using 10 questions, each on a 0-5 point scale. Scale range is 0-50 with higher numbers signifying worse quality of life.
Time Frame
Two weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle Dossett, MD, PhD, MPH
Organizational Affiliation
Beth Israel Deaconess Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26422466
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.
Results Reference
result
Links:
URL
http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0136855
Description
study manuscript

Learn more about this trial

Response to Supplement and Placebo in GERD

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