Determining Risk Factors for Successful PPI Weaning

Gastroesophageal Reflux Disease ("GERD") can happen when stomach acid flows backward into your esophagus (tube from the mouth to the stomach), causing symptoms such as heartburn. Proton pump inhibitors (called "PPIs") are a type of medication that reduce acid in the stomach and are used to reduce the discomfort from GERD. Treatment for GERD with PPIs is recommended to last up to eight weeks; however, many people take them for longer periods. Some people are placed on PPIs (particularly in the hospital) to prevent ulcers and inflammation of the stomach, but they do not need to be on the medication long term. Previous research studies have shown that there are some risks with taking PPIs for a long time. These risks include the inability of your body to absorb some vitamins and minerals, certain infections such as pneumonia or the digestive tract infection called "C. diff," and possibly bone fractures. Therefore, it is desirable to stop taking a PPI when possible.

The purpose of this study is to use a standard approach to help patients stop taking PPIs by adopting lifestyle habits known to reduce the symptoms of GERD while they slowly reduce their PPI dose. All medications used for this study are approved by the U.S. Food and Drug Administration ("FDA"). You are being asked to take part in this study because you have been taking a PPI for longer than the recommended time, and have either a diagnosis of GERD, gastritis, or an unclear indication for being on a PPI. About 100 patients from the Mount Carmel St. Ann's Family Medicine practice will participate in this research.

Study Overview

• Status: Terminated
• Conditions: Gastroesophageal Reflux
• Intervention / Treatment: Behavioral: Lifestyle Modifications

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Westerville, Ohio, United States, 43081
      • Mount Carmel St. Ann's Family Medicine Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• > 18 years old
• Male or female
• PPI on home medication reconciliation
• GERD that is symptom controlled (per questionnaire), OR
• Gastritis that is symptom controlled (per questionnaire), OR
• An unclear indication for PPI use but free of GERD/gastritis/ulcer symptoms (includes patients on GI prophylaxis from the hospital and continued medication)
• Desire or willingness to be off of PPI chronically
• On PPI chronically (> 2 months or 8 weeks, can be intermittent use)
• Initial PPI dose cannot exceed more than the equivalent of Omeprazole 40mg PO BID
• Comprehend English well (per provider's discretion; to understand questionnaires, instructions, etc.)

Exclusion Criteria:

• On PPI for fewer than 2 months
• Co-morbid diagnosis of Peptic Ulcer Disease, H.pylori infection, Barrett's esophagus, malignancy, Inflammatory Bowel Disease
• Diagnosis of moderate to severe renal impairment (defined as CrCl <50 mL/min; reasoning due to caution of H2RB on renal failure)
• Diagnosis of prolonged QT interval with renal impairment (reasoning due to H2RB with concomitant renal failure may increase QT interval if not renally dosed)
• True allergy to Proton Pump Inhibitor and / or H2 Receptor Blocker
• Patients with frequent cardiac angina symptoms (decreasing the dose of PPI may cause rebound GERD and the patient may think they are having a heart attack)
• Pregnant women, fetuses, neonates or fetal material
• Females of reproductive potential at time of research that are not on a form on birth control (OCPs, tubal ligation, etc) or lactating
• Adults with decisional impairment
• Prisoners
• Patients with uncontrolled Psychological illness

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: PPI Taper; PPI Taper using Lifestyle Modifications, per study protocol	Behavioral: Lifestyle Modifications; Lifestyle Modifications to wean off of a Proton Pump Inhibitor, i.e. avoiding dietary triggers, waiting 3 hours to lie flat, and elevating the head of the bed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Successful Weaning off a Proton Pump Inhibitor	To eliminate GERD/gastritis symptoms and completely discontinue PPI use	6 months

Collaborators and Investigators

• Sponsor: Mount Carmel Health System
• Investigators: Principal Investigator: Stephanie O Meller, MD, Mount Carmel Health System

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2016
• Primary Completion (ACTUAL): October 1, 2018
• Study Completion (ACTUAL): October 1, 2018

Study Registration Dates

• First Submitted: July 19, 2017
• First Submitted That Met QC Criteria: July 19, 2017
• First Posted (ACTUAL): July 21, 2017

Study Record Updates

• Last Update Posted (ACTUAL): December 4, 2018
• Last Update Submitted That Met QC Criteria: December 2, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: Proton Pump Inhibitor
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastroesophageal Reflux
• Other Study ID Numbers: 160809-6

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to share data at this time.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No