Gastroesophageal RefluxNCT03226054
Determining Risk Factors for Successful PPI Weaning
A study testing Lifestyle Modifications in people with Gastroesophageal Reflux, run by Mount Carmel Health System at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gastroesophageal Reflux
- What is being tested?
- Lifestyle Modifications
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2016to 1 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- > 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)
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- 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.)
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Mount Carmel St. Ann's Family Medicine Center
Westerville, Ohio, 43081
About this study
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.
- Conditions
- Gastroesophageal Reflux
- Being tested
- Lifestyle Modifications
- Keywords
- Proton Pump Inhibitor
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle ModificationsBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| PPI Taper | Other | PPI Taper using Lifestyle Modifications, per study protocol Receives: Behavioral: Lifestyle Modifications |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful Weaning off a Proton Pump Inhibitor
To eliminate GERD/gastritis symptoms and completely discontinue PPI use
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study start1 Sep 2016
- Primary completion1 Oct 2018
- Study completion1 Oct 2018
Why it stopped: Not logistically feasible to continue enrolling patients.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal RefluxStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective Cohort
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mount Carmel Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephanie Meller, Mount Carmel Health System
- Investigators
- Stephanie O Meller, MD, Principal investigator, Mount Carmel Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03226054
- Sponsor's protocol ID
- 160809-6
- Status last verified
- Dec 2018
- First submitted
- 19 Jul 2017
- Last updated
- 4 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share data at this time.
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining Risk Factors for Successful PPI Weaning
- ClinicalTrials.gov ID
- NCT03226054
- Acronym / sponsor ID
- 160809-6
- Conditions
- Gastroesophageal Reflux
- Keywords
- Proton Pump Inhibitor
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Not logistically feasible to continue enrolling patients.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Mount Carmel Health SystemUniversity, hospital or other
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 1 Oct 2018 (actual)
- Study completion
- 1 Oct 2018 (actual)
- First posted
- 21 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective Cohort
| Arm | Type | Receives |
|---|---|---|
| PPI Taper | Other | Behavioral: Lifestyle ModificationsPPI Taper using Lifestyle Modifications, per study protocol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- > 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifestyle ModificationsLifestyle 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 | Behavioural | PPI Taper |
Primary outcome
Successful Weaning off a Proton Pump Inhibitor
Time frame: 6 months
To eliminate GERD/gastritis symptoms and completely discontinue PPI use
Results and safety
The study was stopped early (reason given: Not logistically feasible to continue enrolling patients.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2018.
- Individual participant dataSharing planned: No. There is no plan to share data at this time.
Related trials for Gastroesophageal Reflux
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephanie O Meller, MD principal investigator
Mount Carmel Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle Modifications in people with Gastroesophageal Reflux, run by Mount Carmel Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Not logistically feasible to continue enrolling patients.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful Weaning off a Proton Pump Inhibitor (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2018.