Gastroesophageal Reflux DiseaseNCT01078064
Gastric Accommodation and Gastroesophageal Reflux
An observational study of Gastroesophageal Reflux Disease, run by Nationwide Children's Hospital at 1 site in United States.
Trial summary
Gastroesophageal reflux events generally happen during relaxation of lower esophageal sphincter. This relaxation is a reflex that is triggered by gastric stimuli. The investigators hypothesize that abnormal relaxation of the gastric wall after a meal may lead to reflux events. Read more about this study
- Who is it for?
- Ages 1 year to 30 years
- Conditions the study is for
- Gastroesophageal Reflux Disease
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Nov 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 1 year to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: children and adolescents older than 1-year old who were referred for combined esophageal impedance pH monitoring for GERD symptoms, such as epigastric pain, respiratory symptoms, heartburn, feeding difficulties, chest pain, nausea or vomiting.
Who may be able to join
- children and adolescents older than 1-year old who were referred for combined esophageal impedance pH monitoring for GERD* symptoms
Who cannot join
- continuous feeding
- previous fundoplication
Trial locations and contacts
1 site in 1 country.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
Official title: Gastric Accommodation as a Factor Influencing the Number of Reflux Episodes in Children and Adolescents
Gastroesophageal reflux events generally happen during relaxation of lower esophageal sphincter. This relaxation is a reflex that is triggered by gastric stimuli. The investigators hypothesize that abnormal relaxation of the gastric wall after a meal may lead to reflux events. To test this hypothesis, a study was designed to measure the gastric accommodation in patients undergoing esophageal impedance monitoring.
Read the detailed description
Gastroesophageal reflux events happen during relaxations of lower esophageal sphincter not related to swallowing, called transient. These transient lower esophageal sphincter relaxations (tLESR) are generally triggered by gastric distension and its physiological purpose is to vent the stomach. The gastric accommodation is a physiological process in which the gastric fundus actively relaxes during a meal in order to accommodate it.
This study is driven by the hypothesis that impairment of the gastric accommodation may facilitate triggering tLESR and, therefore, reflux events. We aim to evaluate the relation between gastric fundic relaxation and the number of gastroesophageal reflux events in children. We also aim to evaluate if there is a relation between the gastric emptying and the number of reflux episodes.
- Conditions
- Gastroesophageal Reflux Disease
- Keywords
- Gastroesophageal reflux disease, gastric motility
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Patients with symptoms suggesting gastroesophageal reflux and referred to perform an impedance study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
NUMBER OF REFLUX EPISODES
It is a cross-sectional exam, and the number of reflux episodes at baseline, after a clinically indicated 24-hour impedance study
Measured: 1 day
Secondary outcomes (1)
Gastric volume ratio: 10 min/baseline
It is a cross-sectional study. This variable will be assessed by ultrasound in the next morning of the impedance study.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionNov 2010
- Study completionNov 2010
Why it stopped: the study failed in recruiting the required number of subjects (sample size) during its period
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal Reflux DiseaseStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nationwide Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rodrigo Strehl Machado, Nationwide Children's Hospital
- Investigators
- Rodrigo S Machado, MD, PhD, Principal investigator, Nationwide Children's HospitalBeth Skaggs, CCRC, Study director, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01078064
- Sponsor's protocol ID
- 001-2010
- Status last verified
- Mar 2019
- First submitted
- 25 Feb 2010
- Last updated
- 21 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastric Accommodation as a Factor Influencing the Number of Reflux Episodes in Children and Adolescents
- ClinicalTrials.gov ID
- NCT01078064
- Acronym / sponsor ID
- 001-2010
- Conditions
- Gastroesophageal Reflux Disease
- Keywords
- Gastroesophageal reflux disease, gastric motility
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: the study failed in recruiting the required number of subjects (sample size) during its period
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Nationwide Children's HospitalUniversity, hospital or other
- Study start
- Mar 2010 (actual)
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 2 Mar 2010 (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.
Gastroesophageal reflux events generally happen during relaxation of lower esophageal sphincter. This relaxation is a reflex that is triggered by gastric stimuli. The investigators hypothesize that abnormal relaxation of the gastric wall after a meal may lead to reflux events. To test this hypothesis, a study was designed to measure the gastric accommodation in patients undergoing esophageal impedance monitoring.
Detailed description
Gastroesophageal reflux events happen during relaxations of lower esophageal sphincter not related to swallowing, called transient. These transient lower esophageal sphincter relaxations (tLESR) are generally triggered by gastric distension and its physiological purpose is to vent the stomach. The gastric accommodation is a physiological process in which the gastric fundus actively relaxes during a meal in order to accommodate it.
This study is driven by the hypothesis that impairment of the gastric accommodation may facilitate triggering tLESR and, therefore, reflux events. We aim to evaluate the relation between gastric fundic relaxation and the number of gastroesophageal reflux events in children. We also aim to evaluate if there is a relation between the gastric emptying and the number of reflux episodes.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | –Patients with symptoms suggesting gastroesophageal reflux and referred to perform an impedance study. |
Who may qualify
- Ages
- 1 year to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- children and adolescents older than 1-year old who were referred for combined esophageal impedance pH monitoring for GERD symptoms, such as epigastric pain, respiratory symptoms, heartburn, feeding difficulties, chest pain, nausea or vomiting.
Key inclusion criteria (1 listed)
- children and adolescents older than 1-year old who were referred for combined esophageal impedance pH monitoring for GERD* symptoms
Key exclusion criteria (2 listed)
- continuous feeding
- previous fundoplication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
NUMBER OF REFLUX EPISODES
Time frame: 1 day
It is a cross-sectional exam, and the number of reflux episodes at baseline, after a clinically indicated 24-hour impedance study
1 secondary outcome
Gastric volume ratio: 10 min/baseline
Time frame: 1 day
Results and safety
The study was stopped early (reason given: the study failed in recruiting the required number of subjects (sample size) during its period). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2019.
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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.
Rodrigo S Machado, MD, PhD principal investigator
Nationwide Children's Hospital
Beth Skaggs, CCRC study director
Nationwide Children's Hospital
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 Disease, run by Nationwide Children's Hospital 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 1 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: stopped early, as of the sponsor's last update on 21 Mar 2019. 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: the study failed in recruiting the required number of subjects (sample size) during its period). 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?
NUMBER OF REFLUX EPISODES (time frame: 1 day). 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 21 Mar 2019.