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Determining Risk Factors for Successful PPI Weaning

Primary Purpose

Gastroesophageal Reflux

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Lifestyle Modifications

About this trial

This is an interventional prevention trial for Gastroesophageal Reflux focused on measuring Proton Pump Inhibitor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Mount Carmel St. Ann's Family Medicine Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

PPI Taper

Arm Description

PPI Taper using Lifestyle Modifications, per study protocol

Outcomes

Primary Outcome Measures

Successful Weaning off a Proton Pump Inhibitor

To eliminate GERD/gastritis symptoms and completely discontinue PPI use

Secondary Outcome Measures

Full Information

NCT ID

NCT03226054

First Posted

July 19, 2017

Last Updated

December 2, 2018

Sponsor

Mount Carmel Health System

1. Study Identification

Unique Protocol Identification Number

NCT03226054

Brief Title

Determining Risk Factors for Successful PPI Weaning

Official Title

Determining Risk Factors for Successful PPI Weaning

Study Type

Interventional

2. Study Status

Record Verification Date

December 2018

Overall Recruitment Status

Terminated

Why Stopped

Not logistically feasible to continue enrolling patients.

Study Start Date

September 1, 2016 (Actual)

Primary Completion Date

October 1, 2018 (Actual)

Study Completion Date

October 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mount Carmel Health System

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastroesophageal Reflux

Keywords

Proton Pump Inhibitor

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Prospective Cohort

Masking

None (Open Label)

Allocation

N/A

Enrollment

5 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PPI Taper

Arm Type

Other

Arm Description

PPI Taper using Lifestyle Modifications, per study protocol

Intervention Type

Behavioral

Intervention Name(s)

Lifestyle Modifications

Intervention Description

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

Primary Outcome Measure Information:

Title

Successful Weaning off a Proton Pump Inhibitor

Description

To eliminate GERD/gastritis symptoms and completely discontinue PPI use

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Stephanie O Meller, MD

Organizational Affiliation

Mount Carmel Health System

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mount Carmel St. Ann's Family Medicine Center

City

Westerville

State/Province

Ohio

ZIP/Postal Code

43081

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

There is no plan to share data at this time.

Learn more about this trial

Determining Risk Factors for Successful PPI Weaning

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