Response to Supplement and Placebo in GERD

NCT01915173 | Completed Results DMC

• 2 other identifiers: 2012P000409IND 117358
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastroesophageal Reflux Disease (GERD); Heartburn; Dyspepsia

Keywords

Gastroesophageal reflux disease (GERD); Heartburn; Dyspepsia

Outcome Measures

Primary Outcomes (1)

• 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.

  2 week follow-up

Secondary Outcomes (2)

• Number of Subjects With a 50% or Greater Decrease in GERD Symptom Severity

  Second week of the trial compared to pre-trial baseline

• GERD Health-Related Quality of Life at Follow-up

  Two weeks

Study Arms (4)

Supplement + Expanded Interview

EXPERIMENTAL

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

Drug: Supplement; Behavioral: Expanded Interview

Placebo + Standard Interview

PLACEBO COMPARATOR

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

Drug: Placebo; Behavioral: Standard Interview

Supplement + Standard Interview

EXPERIMENTAL

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

Drug: Supplement; Behavioral: Standard Interview

Placebo + Expanded Interview

PLACEBO COMPARATOR

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

Drug: Placebo; Behavioral: Expanded Interview

Interventions

Supplement DRUG

Abies nigra 4C, Carbo vegetabilis 4C, Nux vomica 4C, and Robinia pseudoacacia 4C

Supplement + Expanded Interview; Supplement + Standard Interview

Placebo DRUG

Lactose tablets

Placebo + Expanded Interview; Placebo + Standard Interview

Expanded Interview BEHAVIORAL

Placebo + Expanded Interview; Supplement + Expanded Interview

Standard Interview BEHAVIORAL

Placebo + Standard Interview; Supplement + Standard Interview

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult humans age 18-80.
• Fluency in written and spoken English.
• Heartburn symptoms 3 or more days per week for the past month.

You may not qualify if:

• 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

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

• 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.

  PMID: 26422466 RESULT

Related Links

• study manuscript

MeSH Terms

Conditions

Gastroesophageal Reflux; Heartburn; Dyspepsia

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Limitations and Caveats

Small, pilot study.

Results Point of Contact

• Title: Michelle L. Dossett, MD, PhD, MPH
• Organization: Massachusetts General Hospital

mdossett@mgh.harvard.edu

617-643-6034

Study Officials

• Michelle Dossett, MD, PhD, MPH

  Beth Israel Deaconess Medical Center

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: July 30, 2013
• First Posted: August 2, 2013
• Study Start: June 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: March 29, 2017
• Results First Posted: March 29, 2017

Record last verified: 2016-12

Locations

US (1)