NCT03226054

Determining Risk Factors for Successful PPI Weaning

Terminated NA Last updated 4 December 2018

What this trial tests

NA trial testing Lifestyle Modifications in Gastroesophageal Reflux in 5 participants. Terminated before completion.

Timeline

1 September 2016

Primary endpoint
1 October 2018

1 October 2018

Quick facts

Lead sponsor	Mount Carmel Health System
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	5
Start date	1 September 2016
Primary completion	1 October 2018
Estimated completion	1 October 2018
Sites	1 location across United States

Drugs / interventions tested

• Lifestyle Modifications

Conditions studied

• Gastroesophageal Reflux — all drugs for Gastroesophageal Reflux →

Sponsor

Mount Carmel Health System — full company profile →

Who can join

18 and older, any sex, with Gastroesophageal Reflux. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.