Identify Normal MII-pH ParametersNCT01566383
Assessing Normal Multichannel Intraluminal Impedance (MII)-pH Parameters for Today's Population
A study testing 24-hr pH monitoring in people with Identify Normal MII-pH Parameters, run by Vanderbilt University Medical Center at 2 sites in United States.
Trial summary
The normal values of a Multichannel Intraluminal Impedance (MII)-pH study can vary between ages, gender, race and different values of body mass index (BMI). This fact can cause new modifications in the normal values such as making new scales for different age groups or BMI groups. Read more about this study
- Who is it for?
- Ages 33 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Identify Normal MII-pH Parameters
- What is being tested?
- 24-hr pH monitoring
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2012to 27 Aug 2013
- 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 33 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male and female adults between the ages of 33-65
- BMI range of 23.9 - 38.9
- Ability to give consent to participate in study
Who cannot join
- History of extraesophageal reflux disease symptoms such as chronic or acute cough and/or throat clearing and /or non-cardiac chest pain.
- History of gastroesophageal reflux disease (GERD) such as heartburn and/or regurgitation.
- History of proton pump inhibitor (PPI) usage ten days prior to the procedure (MII-pH) or H2RA's two days prior to MII-pH and antacids usage on the procedure day.
- History of thoracic, gastric or esophageal surgery.
- Histories of Diabetes Mellitus, neurological disorders, gastrointestinal disease, taking medication that alter the intragastric acidity or esophageal motility.
- Pregnancy or nursing mothers.
- Alcohol consumption >40g/day, smoking >10cigarettes/day.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Vanderbilt University Medical Center
Nashville, Tennessee, 37212
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
The normal values of a Multichannel Intraluminal Impedance (MII)-pH study can vary between ages, gender, race and different values of body mass index (BMI). This fact can cause new modifications in the normal values such as making new scales for different age groups or BMI groups.
Our aim is to find the normal esophageal MII-pH parameter ranges in volunteers who never experienced reflux related symptoms and are in between the same ranges of age and BMI of our gastroesophageal reflux disease (GERD) patient population.
- Conditions
- Identify Normal MII-pH Parameters
- Being tested
- 24-hr pH monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
24-hr pH monitoringProcedure or surgery
Visit 1
The following will be done:
- A medical history including review of your current drugs;
- Collection of demographic information;
- A manometry, before the 24-hour pH testing, to find the junction between the esophagus and stomach;
- 24-hour pH testing will be done
Visit 2
You will return to the clinic 24 hours after the visit 1 and the following will occur:
- The catheter will be removed from your nose; and
- You will return the recording device
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | Experimental | Healthy volunteers who are matched (age, weight, gender) to the general patient population undergoing manometry and pH monitoring for GERD will undergo the same procedures to determine pH levels in people without reflux symptoms as compared to pH levels in those patients who have been diagnosed with reflux. Receives: Procedure: 24-hr pH monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify normal esophageal MII-pH parameter ranges in healthy volunteers
Our aim is to find the normal esophageal MII-pH parameter ranges in volunteers who never experienced reflux related symptoms and are in between the same ranges of age and BMI of our GERD patient population.
Measured: Following 24-hr pH monitoring
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2012 (estimated)
- Study startMar 2012
- Primary completion27 Aug 2013
- Study completion27 Aug 2013
Why it stopped: unable to meet recruitment goals
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Identify Normal MII-pH ParametersStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Vaezi, Vanderbilt University Medical Center
- Investigators
- Michael F Vaezi, MD, PhD, Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01566383
- Sponsor's protocol ID
- 120288
- Status last verified
- Feb 2017
- First submitted
- 26 Mar 2012
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Normal Multichannel Intraluminal Impedance (MII)-pH Parameters for Today's Population
- ClinicalTrials.gov ID
- NCT01566383
- Acronym / sponsor ID
- 120288
- Conditions
- Identify Normal MII-pH Parameters
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: unable to meet recruitment goals
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- 27 Aug 2013 (actual)
- Study completion
- 27 Aug 2013 (actual)
- First posted
- 29 Mar 2012 (estimated)
- 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.
The normal values of a Multichannel Intraluminal Impedance (MII)-pH study can vary between ages, gender, race and different values of body mass index (BMI). This fact can cause new modifications in the normal values such as making new scales for different age groups or BMI groups.
Our aim is to find the normal esophageal MII-pH parameter ranges in volunteers who never experienced reflux related symptoms and are in between the same ranges of age and BMI of our gastroesophageal reflux disease (GERD) patient population.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | Experimental | Procedure: 24-hr pH monitoringHealthy volunteers who are matched (age, weight, gender) to the general patient population undergoing manometry and pH monitoring for GERD will undergo the same procedures to determine pH levels in people without reflux symptoms as compared to pH levels in those patients who have been diagnosed with reflux. |
Who may qualify
- Ages
- 33 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy male and female adults between the ages of 33-65
- BMI range of 23.9 - 38.9
- Ability to give consent to participate in study
Key exclusion criteria (7 listed)
- History of extraesophageal reflux disease symptoms such as chronic or acute cough and/or throat clearing and /or non-cardiac chest pain.
- History of gastroesophageal reflux disease (GERD) such as heartburn and/or regurgitation.
- History of proton pump inhibitor (PPI) usage ten days prior to the procedure (MII-pH) or H2RA's two days prior to MII-pH and antacids usage on the procedure day.
- History of thoracic, gastric or esophageal surgery.
- Histories of Diabetes Mellitus, neurological disorders, gastrointestinal disease, taking medication that alter the intragastric acidity or esophageal motility.
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 |
|---|---|---|
| 24-hr pH monitoringVisit 1 The following will be done: * A medical history including review of your current drugs; * Collection of demographic information; * A manometry, before the 24-hour pH testing, to find the junction between the esophagus and stomach; * 24-hour pH testing will be done Visit 2 You will return to the clinic 24 hours after the visit 1 and the following will occur: * The catheter will be removed from your nose; and * You will return the recording device | Procedure or surgery | Healthy Volunteers |
Primary outcome
Identify normal esophageal MII-pH parameter ranges in healthy volunteers
Time frame: Following 24-hr pH monitoring
Our aim is to find the normal esophageal MII-pH parameter ranges in volunteers who never experienced reflux related symptoms and are in between the same ranges of age and BMI of our GERD patient population.
Results and safety
The study was stopped early (reason given: unable to meet recruitment goals). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
- Individual participant dataSharing planned: No
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.
Michael F Vaezi, MD, PhD principal investigator
Vanderbilt University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 24-hr pH monitoring in people with Identify Normal MII-pH Parameters, run by Vanderbilt University Medical Center at 2 sites 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 3 inclusion and 7 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 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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: unable to meet recruitment goals). 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?
Identify normal esophageal MII-pH parameter ranges in healthy volunteers (time frame: Following 24-hr pH monitoring). 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 23 Feb 2017.