Clinical Trials Directory

Trials / Completed

CompletedNCT02542579

Gastric and Duodenal Microbiota in Dyspeptic Subjects

Composition of Gastric and Duodenal Microbiota in Dyspeptic Subjects

Status
Completed
Phase
Study type
Observational
Enrollment
98 (actual)
Sponsor
Konkuk University Medical Center · Academic / Other
Sex
All
Age
20 Years
Healthy volunteers
Not accepted

Summary

The composition of gastric microbiota is determined by the status of Helicobacter pylori infection. In subjects who have never been infected by H. pylori, gastric microbiota includes various bacteria, creating ideal microbial diversity. This ideal microbial diversity is destroyed by H. pylori infection at low intragastric pH. Since it is difficult for most bacteria to proliferate within an acidic stomach, relative H. pylori abundance gives rise to microbial dysbiosis. Conversely, unideal microbial diversity is often observed in infected individuals with impaired gastric secretory ability at hypochlorhydric condition. Bacteria producing carcinogenic N-nitrosamine compounds are often detected in individuals with past or chronic H. pylori infection at high intragastric pH. Nonetheless, microbial imbalance that occurs in the earlier phase before gastric carcinognenesis is uncertain.

Detailed description

Dominant colonization of a specific microbiota leading to dysbiosis may lead to inflammation of the mucosa. We hypothesized that the degree of inflammation depend on the composition of microbiota. This study was aimed to define gastric and duodenal microbiota leading to abnormal histopathology. We further tried to elucidate whether the composition of duodenal microbiota is altered by gastric microbiota. Among the dyspeptic subjects who visited for upper gastrointestinal (UGI) endoscopy, subjects with drug intake (antibiotics, PPIs, laxatives, antidepressants, statins, metformin) within 3 months will be excluded. Three biopsies will performed at the greater curvature side of the mid-antrum, greater curvature side of the mid-body, and at the duodenum, respectively. Next generation sequencing analysis will be performed for 16S rRNA variable regions using the biopsied samples. Primary study endpoint is 16S rRNA sequencing findings of gastric and duodenal microbiota. Secondary endpoints are microbiota linked with higher degrees of inflammation, activity, atrophy and intestinal metaplasia based on the updated Sydney classification. Furthermore, correlation between the microbiota and endoscopy finding will be analyzed.

Conditions

Interventions

TypeNameDescription
GENETIC16S rRNA pyrosequencing analysisNext generation sequencing analysis will be done for 16S rRNA V1,2 hypervariable regions at Biocore (Seoul, Korea).

Timeline

Start date
2016-06-01
Primary completion
2018-03-01
Completion
2018-08-01
First posted
2015-09-07
Last updated
2018-08-07

Locations

2 sites across 1 country: South Korea

Source: ClinicalTrials.gov record NCT02542579. Inclusion in this directory is not an endorsement.