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

NCT04248296 | Completed

• 1 other identifier: 53677316.7.0000.0068
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Gastroesophageal Reflux Disease With Esophagitis

Keywords

Gastroesophageal Reflux; intestinal microbiome

Outcome Measures

Primary Outcomes (1)

• 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%.

  2017-2018

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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).

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Hospital das Clinicas da FMUSP

São Paulo, 04014-020, Brazil

Location

Biospecimen

Retention: SAMPLES WITH DNA

Microbiome DNA was extracted from stool samples, and PCR amplification was performed using primers for the V4 region of the 16S rRNA gene. The amplicons were sequenced using the Ion PGM Torrent platform, and data were analyzed using QIIME™ software version 1.8 (Quantitative Insights Into Microbial Ecology).

MeSH Terms

Conditions

Esophagitis, Peptic; Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophagitis; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis; Peptic Ulcer; Duodenal Diseases; Intestinal Diseases; Stomach Diseases; Esophageal Motility Disorders; Deglutition Disorders

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2019
• First Posted: January 30, 2020
• Study Start: May 10, 2017
• Primary Completion: February 20, 2019
• Study Completion: February 20, 2019
• Last Updated: January 30, 2020

Record last verified: 2019-09

Locations

BR (1)