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

Sponsor
University of Sao Paulo General Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04248296
Collaborator
(none)
22
Enrollment
1
Location
21.4
Actual Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

. In this study, we investigated intestinal microbiomes, in individuals with Gastroesophageal Reflux Disease and healthy individuals, using metagenomic techniques.

Condition or Disease Intervention/Treatment Phase

    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

    Study Type:
    Observational
    Actual Enrollment :
    22 participants
    Observational Model:
    Other
    Time Perspective:
    Retrospective
    Official Title:
    Evaluate the Intestinal Microbiome in Patients With Erosive Gastroesophageal Reflux Disease and in Asymptomatic Healthy Controls
    Actual Study Start Date :
    May 10, 2017
    Actual Primary Completion Date :
    Feb 20, 2019
    Actual Study Completion Date :
    Feb 20, 2019

    Outcome Measures

    Primary Outcome Measures

    1. Determine the microbiome [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%.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital das Clinicas da FMUSP São Paulo Brazil 04014-020

    Sponsors and Collaborators

    • University of Sao Paulo General Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Sao Paulo General Hospital
    ClinicalTrials.gov Identifier:
    NCT04248296
    Other Study ID Numbers:
    • 53677316.7.0000.0068
    First Posted:
    Jan 30, 2020
    Last Update Posted:
    Jan 30, 2020
    Last Verified:
    Sep 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University of Sao Paulo General Hospital
    Gastroesophageal Reflux
    intestinal microbiome
    Additional relevant MeSH terms:
    Gastroesophageal Reflux
    Esophagitis, Peptic
    Esophagitis

    Study Results

    No Results Posted as of Jan 30, 2020