Gastric and Duodenal Microbiota in Dyspeptic Subjects

NCT ID: NCT02542579

Last Updated: 2018-08-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 98 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2018-08-31

Brief 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

Microbial Colonization; Gastritis

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Subjects for pyrosequencing analysis

Dyspeptic subjects who visited for evaluation and agreed on 16S rRNA pyrosequencing analysis

16S rRNA pyrosequencing analysis

Intervention Type: GENETIC

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

Interventions

16S rRNA pyrosequencing analysis

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

Intervention Type: GENETIC

Eligibility Criteria

Inclusion Criteria

• Dyspeptic subjects who visited for evaluation including upper gastrointestinal endoscopy and biopsies
• Age >20 years old

Exclusion Criteria

• Underlying disease(s) that requires managements
• Recent intake of drug(s)
• History of gastrectomy

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Konkuk University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Sun-Young Lee

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sun-Young Lee, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Konkuk University

Locations

Konkuk University Medical Center

Seoul, , South Korea

Konkuk University Medical Center

Seoul, , South Korea

Countries

South Korea

References

Lee SY, Moon HW, Hur M, Yun YM. Validation of western Helicobacter pylori IgG antibody assays in Korean adults. J Med Microbiol. 2015 May;64(Pt 5):513-518. doi: 10.1099/jmm.0.000050. Epub 2015 Mar 9.

Reference Type: BACKGROUND

PMID: 25752852 (View on PubMed)

Lee SP, Lee SY, Kim JH, Sung IK, Park HS, Shim CS, Moon HW. Correlation between Helicobacter pylori infection, IgE hypersensitivity, and allergic disease in Korean adults. Helicobacter. 2015 Feb;20(1):49-55. doi: 10.1111/hel.12173. Epub 2014 Sep 25.

Reference Type: BACKGROUND

PMID: 25257099 (View on PubMed)

Lee SY. Future candidates for indications of Helicobacter pylori eradication: do the indications need to be revised? J Gastroenterol Hepatol. 2012 Feb;27(2):200-11. doi: 10.1111/j.1440-1746.2011.06961.x.

Reference Type: BACKGROUND

PMID: 22098099 (View on PubMed)

Other Identifiers

KUH1010691

Identifier Type: -

Identifier Source: org_study_id