Disorder of Upper Esophageal SphincterNCT05493436
The Influence of Obesity to Esophageal Reflux Severity Measured by pH-Metri Impedans on Gastroesophageal Reflux Disease Patients
An observational study of Disorder of Upper Esophageal Sphincter, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
To see a more convincing relationship between increased body mass index and the severity of esophageal reflux in GERD patients, GERD diagnosis should be performed with greater precision or precision. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Disorder of Upper Esophageal Sphincter
- What is being tested?
- MII pH-meter
- How many people
- 98 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Apr 2017to 1 Jul 2018
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: patients with GERD
Who may be able to join
- GERD patients diagnosed by GerdQ
- Adult patient age 18-60 years
- Patients with nutritional status based on normal BMI (18.5-24.9) and obesity (≥30)
- Willing to participate in research and sign informed consent
Who cannot join
- At the endoscopic examination found Barrett's esophagus, peptic ulcer, severe gastritis, severe NSAID gastropathy, hemorrhage (melenae), gastric cancer, esophageal cancer
- MII-pH check failed to install
- Patients are not cooperative
- Patients with acute psychiatric disorders
- Patients with severe heart trouble, persistent asthma patients, decompensated liver cirrhosis and chronic renal disease
Trial locations and contacts
1 site in 1 country.
About this study
To see a more convincing relationship between increased body mass index and the severity of esophageal reflux in GERD patients, GERD diagnosis should be performed with greater precision or precision. From the available data, it appears that no studies in Indonesia have correlated the body mass index with the severity of esophageal reflux events measured by multical intraluminal intraluminal pH-metric in patients with GERD due to the invasive nature of the test. Therefore, research needs to be done to assess the effect of increased body mass index on the severity of esophageal reflux as measured by multical intraluminal impedance pH-metric in GERD patients.
Read the detailed description
Gastroesophageal reflux disease (GERD) prevalence is increasing worldwide. It is known that GERD correlates with obesity. In order to see further association between obesity and severity degree of esophageal reflux, GERD must be diagnosed with greater precision and accuracy. Therefore, study to see the impact of obesity in esophageal reflux severity measured by multicanal intraluminal impedance pH-meter (MII-pH) in GERD patient is compulsory.
The objective of this study is to explain the impact of obesity on severity of esophageal reflux in GERD patient measured by DeMeester score, hiatal hernia incidence, and the prolongation of acid exposure time in GERD patient.
This cross-sectional study recruited patients from Gastroenterology Clinic, Internal Medicine Department Cipto Mangunkusumo Hospital during May-August 2017. Patient with normal and obese body mass index (BMI) suspected having GERD were surveyed using GERDQ to diagnose GERD in these patients. Upper gastrointestinal endoscopy were performed to see hiatal hernia. All patients recruited underwent MII-pH examination to measure DeMeester score and acid exposure time. Results were analyzed using bivariat analysis.
- Conditions
- Disorder of Upper Esophageal Sphincter
- Being tested
- MII pH-meter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MII pH-meterDiagnostic test
using multichannel impedance pH-meter
| Study group | Role | What they receive |
|---|---|---|
| normoweight | GERD patient with normoweight was evaluating by MII pH-meter Receives: Diagnostic Test: MII pH-meter | |
| obesity | GERD patient with obesity was evaluating by MII pH-meter Receives: Diagnostic Test: MII pH-meter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite pH score/DeMesster Score
Participants underwent multichannel intraluminal impedance pH-meter (MII-pH) monitoring for quantification of the DeMeester score and acid exposure time
Measured: January 2017 - October 2017
Secondary outcomes (3)
Acid exposure time
Percent of acid exposure time (AET) at pH < 4 for each study groups
Measured: January 2017 - October 2017
Incidence of Hiatal Hernia
Incidence of hiatal hernia is measured for each group
Measured: January 2017 - October 2017
Incidence of Erosive Esophagitis
Incidence of erosive esophagitis is measured for each group
Measured: January 2017 - October 2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2022
- Study start1 Apr 2017
- Primary completion1 Oct 2017
- Study completion1 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disorder of Upper Esophageal SphincterStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ari Fahrial Syam, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05493436
- Sponsor's protocol ID
- IndonesiaSatu
- Status last verified
- Aug 2022
- First submitted
- 12 Aug 2020
- Last updated
- 9 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 9 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Obesity to Esophageal Reflux Severity Measured by pH-Metri Impedans on Gastroesophageal Reflux Disease Patients
- ClinicalTrials.gov ID
- NCT05493436
- Acronym / sponsor ID
- IndonesiaSatu
- Conditions
- Disorder of Upper Esophageal Sphincter
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 1 Oct 2017 (actual)
- Study completion
- 1 Jul 2018 (actual)
- First posted
- 9 Aug 2022 (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.
To see a more convincing relationship between increased body mass index and the severity of esophageal reflux in GERD patients, GERD diagnosis should be performed with greater precision or precision. From the available data, it appears that no studies in Indonesia have correlated the body mass index with the severity of esophageal reflux events measured by multical intraluminal intraluminal pH-metric in patients with GERD due to the invasive nature of the test. Therefore, research needs to be done to assess the effect of increased body mass index on the severity of esophageal reflux as measured by multical intraluminal impedance pH-metric in GERD patients.
Detailed description
Gastroesophageal reflux disease (GERD) prevalence is increasing worldwide. It is known that GERD correlates with obesity. In order to see further association between obesity and severity degree of esophageal reflux, GERD must be diagnosed with greater precision and accuracy. Therefore, study to see the impact of obesity in esophageal reflux severity measured by multicanal intraluminal impedance pH-meter (MII-pH) in GERD patient is compulsory.
The objective of this study is to explain the impact of obesity on severity of esophageal reflux in GERD patient measured by DeMeester score, hiatal hernia incidence, and the prolongation of acid exposure time in GERD patient.
This cross-sectional study recruited patients from Gastroenterology Clinic, Internal Medicine Department Cipto Mangunkusumo Hospital during May-August 2017. Patient with normal and obese body mass index (BMI) suspected having GERD were surveyed using GERDQ to diagnose GERD in these patients. Upper gastrointestinal endoscopy were performed to see hiatal hernia. All patients recruited underwent MII-pH examination to measure DeMeester score and acid exposure time. Results were analyzed using bivariat analysis.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| normoweight | – | Diagnostic Test: MII pH-meterGERD patient with normoweight was evaluating by MII pH-meter |
| obesity | – | Diagnostic Test: MII pH-meterGERD patient with obesity was evaluating by MII pH-meter |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- patients with GERD
Key inclusion criteria (4 listed)
- GERD patients diagnosed by GerdQ
- Adult patient age 18-60 years
- Patients with nutritional status based on normal BMI (18.5-24.9) and obesity (≥30)
- Willing to participate in research and sign informed consent
Key exclusion criteria (5 listed)
- At the endoscopic examination found Barrett's esophagus, peptic ulcer, severe gastritis, severe NSAID gastropathy, hemorrhage (melenae), gastric cancer, esophageal cancer
- MII-pH check failed to install
- Patients are not cooperative
- Patients with acute psychiatric disorders
- Patients with severe heart trouble, persistent asthma patients, decompensated liver cirrhosis and chronic renal disease
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 |
|---|---|---|
| MII pH-meterusing multichannel impedance pH-meter | Diagnostic test | normoweight, obesity |
Primary outcome
Composite pH score/DeMesster Score
Time frame: January 2017 - October 2017
Participants underwent multichannel intraluminal impedance pH-meter (MII-pH) monitoring for quantification of the DeMeester score and acid exposure time
3 secondary outcomes
Acid exposure time
Time frame: January 2017 - October 2017
Incidence of Hiatal Hernia
Time frame: January 2017 - October 2017
Incidence of Erosive Esophagitis
Time frame: January 2017 - October 2017
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 9 Aug 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Disorder of Upper Esophageal Sphincter, run by Universitas Indonesia at 1 site in Indonesia.
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 4 inclusion and 5 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 9 Aug 2022. 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 Indonesia. 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.
What does the primary outcome measure?
Composite pH score/DeMesster Score (time frame: January 2017 - October 2017). 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 9 Aug 2022; AzTrials last refreshed its copy on 8 Nov 2026.