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Response to Supplement and Placebo in GERD

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ClinicalTrials.gov Identifier: NCT01915173
Recruitment Status : Completed
First Posted : August 2, 2013
Results First Posted : March 29, 2017
Last Update Posted : March 29, 2017
Sponsor:
Information provided by (Responsible Party):
Gloria Y. Yeh, Beth Israel Deaconess Medical Center

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.

Condition or disease Intervention/treatment Phase
Gastroesophageal Reflux Disease (GERD) Heartburn Dyspepsia Drug: Supplement Drug: Placebo Behavioral: Expanded Interview Behavioral: Standard Interview Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Response to Supplement and Placebo in GERD
Study Start Date : June 2013
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Supplement + Expanded Interview
Supplement, 2 tablets sublingually 3 times a day for 2 weeks.
Drug: Supplement
Abies nigra 4C, Carbo vegetabilis 4C, Nux vomica 4C, and Robinia pseudoacacia 4C

Behavioral: Expanded Interview
Placebo Comparator: Placebo + Standard Interview
Placebo, 2 tablets sublingually 3 times a day for 2 weeks.
Drug: Placebo
Lactose tablets

Behavioral: Standard Interview
Experimental: Supplement + Standard Interview
Supplement, 2 tablets sublingually 3 times a day for 2 weeks.
Drug: Supplement
Abies nigra 4C, Carbo vegetabilis 4C, Nux vomica 4C, and Robinia pseudoacacia 4C

Behavioral: Standard Interview
Placebo Comparator: Placebo + Expanded Interview
Placebo, 2 tablets sublingually 3 times a day for 2 weeks.
Drug: Placebo
Lactose tablets

Behavioral: Expanded Interview



Primary Outcome Measures :
  1. Safety - Number of Participants Experiencing a Serious Adverse Event [ Time Frame: 2 week follow-up ]
    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 :
  1. Number of Subjects With a 50% or Greater Decrease in GERD Symptom Severity [ Time Frame: Second week of the trial compared to pre-trial baseline ]
    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.

  2. GERD Health-Related Quality of Life at Follow-up [ Time Frame: Two weeks ]
    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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01915173


Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Investigators
Study Director: Michelle Dossett, MD, PhD, MPH Beth Israel Deaconess Medical Center

Additional Information:
Publications of Results:
Responsible Party: Gloria Y. Yeh, Associate Professor of Medicine, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT01915173     History of Changes
Other Study ID Numbers: 2012P000409
IND 117358 ( Other Identifier: FDA )
First Posted: August 2, 2013    Key Record Dates
Results First Posted: March 29, 2017
Last Update Posted: March 29, 2017
Last Verified: December 2016

Keywords provided by Gloria Y. Yeh, Beth Israel Deaconess Medical Center:
Gastroesophageal reflux disease (GERD)
Heartburn
Dyspepsia

Additional relevant MeSH terms:
Gastroesophageal Reflux
Dyspepsia
Heartburn
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Signs and Symptoms, Digestive
Signs and Symptoms