Evaluate the Intestinal Microbiome in Patients With Erosive Gastroesophageal Reflux Disease and in Asymptomatic Healthy Controls

January 27, 2020 updated by: University of Sao Paulo General Hospital
. In this study, we investigated intestinal microbiomes, in individuals with Gastroesophageal Reflux Disease and healthy individuals, using metagenomic techniques.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

22

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil, 04014-020
        • Hospital das Clínicas da FMUSP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 56 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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).

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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%.
2017-2018

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 10, 2017

Primary Completion (Actual)

February 20, 2019

Study Completion (Actual)

February 20, 2019

Study Registration Dates

First Submitted

September 16, 2019

First Submitted That Met QC Criteria

January 27, 2020

First Posted (Actual)

January 30, 2020

Study Record Updates

Last Update Posted (Actual)

January 30, 2020

Last Update Submitted That Met QC Criteria

January 27, 2020

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 53677316.7.0000.0068

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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