Gastroesophageal Reflux Disease With EsophagitisNCT04248296
Evaluate the Intestinal Microbiome in Patients With Erosive Gastroesophageal Reflux Disease and in Asymptomatic Healthy Controls
An observational study of Gastroesophageal Reflux Disease With Esophagitis, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
. In this study, we investigated intestinal microbiomes, in individuals with Gastroesophageal Reflux Disease and healthy individuals, using metagenomic techniques. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastroesophageal Reflux Disease With Esophagitis
- How many people
- 22 participants
- Where
- 1 siteBrazil
- Study dates
- 10 May 2017to 20 Feb 2019
- 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
- Healthy volunteers accepted
- Adult
Study population: : We performed a study comprising fecal samples of 22 adults, aged 18-60 years: 11 with erosive esophagitis (eight male and three female) and 11 healthy controls (ten male and one female).
Who may be able to join
- a confirmed diagnosis of erosive GERD through clinical and endoscopic criteria
- who have not taken omeprazole or any other drug that changes gastric pH in the thirty days prior to the completion of diagnostic tests for GERD and other tests included in the protocol.
Who cannot join
- Use of antimicrobials or probiotics in the last three months
- Presence of severe and/or extensive atrophic gastritis confirmed histologically
- Comorbidities that could interfere with motility of the gastrointestinal tract (diabetes mellitus, previous stroke, neurological diseases)
- Use of drugs that could interfere with motility of the gastrointestinal tract or salivation (calcium channel blockers, nitrates, anticholinergics, estrogens)
- Bulky hiatal hernia (greater than or equal to 5 cm)
- Los Angeles grade C or D erosive esophagitis
Show all 12Show fewer
- Long-distance travel in the last 3 months (outside the southeastern region of the country)
- Pregnant or breastfeeding patients
- Previous history of upper digestive tract surgery
- Obesity (body mass index equal to or greater than 30 kg / m2)
- Patient with a consumptive syndrome or malnutrition
- Tobacco use in the last 30 days / Alcohol use (more than 20 g per day, in the last 30 days)
Trial locations and contacts
1 site in 1 country.
About this study
. In this study, we investigated intestinal microbiomes, in individuals with Gastroesophageal Reflux Disease and healthy individuals, using metagenomic techniques.
Read the detailed description
Background: The pathophysiology of Gastroesophageal Reflux Disease (GERD) involves several mechanisms. Intestinal dysbiosis may influence factors involved in the pathophysiology of Gastroesophageal Reflux Disease, such as changes in gastrointestinal motor patterns and increased intraabdominal pressure due to increased fermentation of non-digestible carbohydrates. However, few studies have focused on assessment of gut microbiome in the GERD. In this study, we investigated intestinal microbiomes, in individuals with Gastroesophageal Reflux Disease and healthy individuals, using metagenomic techniques.
Methods: We performed a study comprising fecal samples of 22 adults, aged 18-60 years: 11 with erosive esophagitis (eight male and three female) and 11 healthy controls (ten male and one female). Microbiome DNA was extracted from stool samples, and polymerase chain reaction amplification was performed using primers for the V4 region of the 16S rRNA gene (16S ribosomal ribonucleic acid). The amplicons were sequenced using the Ion Torrent™ Personal Genome Machine™ platform, and data were analyzed using QIIME™ software version 1.8 (Quantitative Insights Into Microbial Ecology).
- Keywords
- Gastroesophageal Reflux, intestinal microbiome
- Medical subject headings
- Esophagitis, Peptic, Gastroesophageal Reflux
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the microbiome
In this study, we investigated intestinal microbiomes, in individuals with Gastroesophageal Reflux Disease and healthy individuals, using metagenomic techniques. To analyze and compare different samples, we used two types of diversity indices: alpha (α) and beta (β). The relative abundance of the samples was calculated using the non-parametric Mann-Whitney test. Boxplot graphs and tables were generated to compare groups. All tests performed took into account a bidirectional α of 0.05 and a confidence interval (CI) of 95%.
Measured: 2017-2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2020
- Study start10 May 2017
- Primary completion20 Feb 2019
- Study completion20 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal Reflux Disease With EsophagitisStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04248296
- Sponsor's protocol ID
- 53677316.7.0000.0068
- Status last verified
- Sep 2019
- First submitted
- 16 Sep 2019
- Last updated
- 30 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluate the Intestinal Microbiome in Patients With Erosive Gastroesophageal Reflux Disease and in Asymptomatic Healthy Controls
- ClinicalTrials.gov ID
- NCT04248296
- Acronym / sponsor ID
- 53677316.7.0000.0068
- Keywords
- Gastroesophageal Reflux, intestinal microbiome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 10 May 2017 (actual)
- Primary completion
- 20 Feb 2019 (actual)
- Study completion
- 20 Feb 2019 (actual)
- First posted
- 30 Jan 2020 (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.
. In this study, we investigated intestinal microbiomes, in individuals with Gastroesophageal Reflux Disease and healthy individuals, using metagenomic techniques.
Detailed description
Background: The pathophysiology of Gastroesophageal Reflux Disease (GERD) involves several mechanisms. Intestinal dysbiosis may influence factors involved in the pathophysiology of Gastroesophageal Reflux Disease, such as changes in gastrointestinal motor patterns and increased intraabdominal pressure due to increased fermentation of non-digestible carbohydrates. However, few studies have focused on assessment of gut microbiome in the GERD. In this study, we investigated intestinal microbiomes, in individuals with Gastroesophageal Reflux Disease and healthy individuals, using metagenomic techniques.
Methods: We performed a study comprising fecal samples of 22 adults, aged 18-60 years: 11 with erosive esophagitis (eight male and three female) and 11 healthy controls (ten male and one female). Microbiome DNA was extracted from stool samples, and polymerase chain reaction amplification was performed using primers for the V4 region of the 16S rRNA gene (16S ribosomal ribonucleic acid). The amplicons were sequenced using the Ion Torrent™ Personal Genome Machine™ platform, and data were analyzed using QIIME™ software version 1.8 (Quantitative Insights Into Microbial Ecology).
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- : We performed a study comprising fecal samples of 22 adults, aged 18-60 years: 11 with erosive esophagitis (eight male and three female) and 11 healthy controls (ten male and one female).
Key inclusion criteria (2 listed)
- a confirmed diagnosis of erosive GERD through clinical and endoscopic criteria
- who have not taken omeprazole or any other drug that changes gastric pH in the thirty days prior to the completion of diagnostic tests for GERD and other tests included in the protocol.
Key exclusion criteria (12 listed)
- Use of antimicrobials or probiotics in the last three months
- Presence of severe and/or extensive atrophic gastritis confirmed histologically
- Comorbidities that could interfere with motility of the gastrointestinal tract (diabetes mellitus, previous stroke, neurological diseases)
- Use of drugs that could interfere with motility of the gastrointestinal tract or salivation (calcium channel blockers, nitrates, anticholinergics, estrogens)
- Bulky hiatal hernia (greater than or equal to 5 cm)
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
Determine the microbiome
Time frame: 2017-2018
In this study, we investigated intestinal microbiomes, in individuals with Gastroesophageal Reflux Disease and healthy individuals, using metagenomic techniques. To analyze and compare different samples, we used two types of diversity indices: alpha (α) and beta (β). The relative abundance of the samples was calculated using the non-parametric Mann-Whitney test. Boxplot graphs and tables were generated to compare groups. All tests performed took into account a bidirectional α of 0.05 and a confidence interval (CI) of 95%.
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 30 Jan 2020.
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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 Gastroesophageal Reflux Disease With Esophagitis, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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 2 inclusion and 12 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 30 Jan 2020. 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 Brazil. 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?
Determine the microbiome (time frame: 2017-2018). 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 30 Jan 2020.