Gastroesophageal RefluxLTXGERDNCT00455078
GI Reflux in Lung Transplant and Its Relationship to Chronic Rejection
An observational study of Gastroesophageal Reflux, run by University of Chicago at 1 site in United States.
Trial summary
Recent data has suggested that GER (gastric reflux) may worsen after lung transplantation and potentially increase the risk of chronic rejection (CR) after lung transplantation. The purpose of this study is to look at how often GER occurs in the lung transplant population and examine how GER may change the immune… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Gastroesophageal Reflux
- What is being tested?
- esophagogastroduodenoscopy, Standard GER questionnaire (RDQ) and Scintigraphic evaluation of solid gastric emptying
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to Jan 2010
- Phase
- Observational
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects who have undergone pretransplant evaluation and are on the waiting list or subjects transplanted < 18mos.
Who may be able to join
- Patients who are undergoing pre-lung transplant evaluations at the University of Chicago Hospital
- Patients who are capable of becoming pregnant must have a negative pregnancy test prior to consent.
- All patients must be able to give written informed consent.
Who cannot join
- Pre-transplant patients in whom study procedures are contraindicated or patients who are unable to complete all the study procedures.
- Patients who are unable to give consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Reflux in Innate Immunity Activation After Lung Transplantation.
Recent data has suggested that GER (gastric reflux) may worsen after lung transplantation and potentially increase the risk of chronic rejection (CR) after lung transplantation.
The purpose of this study is to look at how often GER occurs in the lung transplant population and examine how GER may change the immune system and cause CR. In this way, we would be able to better identify patients that may benefit from anti-reflux procedures.
Read the detailed description
Part of standard pre-transplant work up includes a gastrointestinal (GI) work-up to check for GER. The following procedures will be done pre-transplant.
- Standard GER questionnaire (RDQ): This is a 12 item questionnaire. This questionnaire will ask questions about any reflux symptoms present.
- Esophagogastroduodenoscopy (EGD): This test will determine evidence of esophageal reflux and presence of a hiatal hernia.
- Scintigraphic evaluation of solid gastric emptying: This measures the speed with which food empties from the stomach and enters the small intestine.
- Twenty-four hour ambulatory pH testing: The ambulatory 24-hour pH monitoring test will monitor the acid in the esophagus during a 24-hour period.
- Esophageal manometry testing: This procedure is done to evaluate the cause of reflux of stomach acid and contents back into the esophagus, and to determine the cause of problems with swallowing food.
These procedures will be done again at 3 to 6 months post transplant. The results of the EGD, scintigraphic evaluation, answers of RDQ, pH testing, esophageal manometry and bronchoscopy will be collected as well as spirometries and any episodes of rejection.
- Conditions
- Gastroesophageal Reflux
- Being tested
- esophagogastroduodenoscopy, Standard GER questionnaire (RDQ), Scintigraphic evaluation of solid gastric emptying, Twenty-four hour ambulatory pH testing, Esophageal manometry testing
- Keywords
- Gastric reflux, Lung transplant, chronic rejection, Gastric reflux in lung transplant as it relates to chronic rejection
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
esophagogastroduodenoscopyProcedure or surgery
EGD will be done pretransplant then again before 18mos post transplant.
Standard GER questionnaire (RDQ)Other
RDQ questionnaire will be done pretransplant then again before 18mos post transplant.
Scintigraphic evaluation of solid gastric emptyingProcedure or surgery
Scintigraphic evaluation of solid gastric emptying will be done pretransplant then again before 18mos post transplant.
Twenty-four hour ambulatory pH testingProcedure or surgery
Twenty-four hour ambulatory pH testing will be done pretransplant then again before 18mos post transplant.
Esophageal manometry testingProcedure or surgery
Esophageal manometry testing will be done pretransplant then again before 18mos post transplant.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2007 (estimated)
- Study startJun 2007
- Primary completionJan 2010
- Study completionJan 2010
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.
- More trials run by University of ChicagoThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sangeeta M. Bhorade, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00455078
- Sponsor's protocol ID
- 15272A
- Acronym
- LTXGERD
- Status last verified
- Sep 2013
- First submitted
- 2 Apr 2007
- Last updated
- 5 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Reflux in Innate Immunity Activation After Lung Transplantation.
- ClinicalTrials.gov ID
- NCT00455078
- Acronym / sponsor ID
- LTXGERD / 15272A
- Conditions
- Gastroesophageal Reflux
- Keywords
- Gastric reflux, Lung transplant, chronic rejection, Gastric reflux in lung transplant as it relates to chronic rejection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 3 Apr 2007 (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.
Recent data has suggested that GER (gastric reflux) may worsen after lung transplantation and potentially increase the risk of chronic rejection (CR) after lung transplantation.
The purpose of this study is to look at how often GER occurs in the lung transplant population and examine how GER may change the immune system and cause CR. In this way, we would be able to better identify patients that may benefit from anti-reflux procedures.
Detailed description
Part of standard pre-transplant work up includes a gastrointestinal (GI) work-up to check for GER. The following procedures will be done pre-transplant.
- Standard GER questionnaire (RDQ): This is a 12 item questionnaire. This questionnaire will ask questions about any reflux symptoms present.
- Esophagogastroduodenoscopy (EGD): This test will determine evidence of esophageal reflux and presence of a hiatal hernia.
- Scintigraphic evaluation of solid gastric emptying: This measures the speed with which food empties from the stomach and enters the small intestine.
- Twenty-four hour ambulatory pH testing: The ambulatory 24-hour pH monitoring test will monitor the acid in the esophagus during a 24-hour period.
- Esophageal manometry testing: This procedure is done to evaluate the cause of reflux of stomach acid and contents back into the esophagus, and to determine the cause of problems with swallowing food.
These procedures will be done again at 3 to 6 months post transplant. The results of the EGD, scintigraphic evaluation, answers of RDQ, pH testing, esophageal manometry and bronchoscopy will be collected as well as spirometries and any episodes of rejection.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who have undergone pretransplant evaluation and are on the waiting list or subjects transplanted < 18mos.
Key inclusion criteria (3 listed)
- Patients who are undergoing pre-lung transplant evaluations at the University of Chicago Hospital
- Patients who are capable of becoming pregnant must have a negative pregnancy test prior to consent.
- All patients must be able to give written informed consent.
Key exclusion criteria (2 listed)
- Pre-transplant patients in whom study procedures are contraindicated or patients who are unable to complete all the study procedures.
- Patients who are unable to give consent
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 |
|---|---|---|
| esophagogastroduodenoscopyEGD will be done pretransplant then again before 18mos post transplant. | Procedure or surgery | – |
| Standard GER questionnaire (RDQ)RDQ questionnaire will be done pretransplant then again before 18mos post transplant. | Other | – |
| Scintigraphic evaluation of solid gastric emptyingScintigraphic evaluation of solid gastric emptying will be done pretransplant then again before 18mos post transplant. | Procedure or surgery | – |
| Twenty-four hour ambulatory pH testingTwenty-four hour ambulatory pH testing will be done pretransplant then again before 18mos post transplant. | Procedure or surgery | – |
| Esophageal manometry testingEsophageal manometry testing will be done pretransplant then again before 18mos post transplant. | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2013.
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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.
Sangeeta M. Bhorade, MD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastroesophageal Reflux, run by University of Chicago 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 3 inclusion and 2 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: finished, as of the sponsor's last update on 5 Sep 2013. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 5 Sep 2013.