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

Gastroesophageal Reflux Disease With Esophagitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04248296
• Other study ID #: 53677316.7.0000.0068
• Status: Completed
• Start date: May 10, 2017
• Est. completion date: February 20, 2019

Study information

• Verified date: September 2019
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: February 20, 2019
• Est. primary completion date: February 20, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• Esophagitis
• Esophagitis, Peptic
• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease With Esophagitis

Locations

Country	Name	City	State
Brazil	Hospital das Clinicas da FMUSP	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 (a) and beta (ß). 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 a of 0.05 and a confidence interval (CI) of 95%.	2017-2018