NCT02542579

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
98

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2016

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 23, 2015

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 7, 2015

Completed
9 months until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

August 7, 2018

Status Verified

August 1, 2018

Enrollment Period

1.7 years

First QC Date

August 23, 2015

Last Update Submit

August 5, 2018

Conditions

Microbial ColonizationGastritis

Keywords

Helicobacter pyloriDyspepsia

Outcome Measures

Primary Outcomes (1)

  • Next generation sequencing analysis for microbiota

    16S rRNA pyrosequencing analysis findings of the gastric and duodenal biopsies

    up to 6 months

Secondary Outcomes (3)

  • Updated Sydney classification

    up to 6 months

  • Gastrointestinal endoscopy finding

    up to 6 months

  • Gastrointestinal symptom and food intake score

    up to 6 months

Study Arms (1)

Subjects for pyrosequencing analysis

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

Genetic: 16S rRNA pyrosequencing analysis

Interventions

16S rRNA pyrosequencing analysisGENETIC

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

Subjects for pyrosequencing analysis

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Dyspeptic subjects for analysis

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Konkuk University Medical Center

Seoul, 05030, South Korea

Location

Konkuk University Medical Center

Seoul, 143729, South Korea

Location

Related Publications (3)

  • 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.

    PMID: 25752852BACKGROUND

  • 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.

    PMID: 25257099BACKGROUND

  • 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.

    PMID: 22098099BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Gastric and duodenal mucosa

MeSH Terms

Conditions

Communicable DiseasesGastritisDyspepsia

Condition Hierarchy (Ancestors)

InfectionsDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesStomach DiseasesSigns and Symptoms, DigestiveSigns and Symptoms

Study Officials

  • Sun-Young Lee, M.D., Ph.D.

    Konkuk University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 23, 2015

First Posted

September 7, 2015

Study Start

June 1, 2016

Primary Completion

March 1, 2018

Study Completion

August 1, 2018

Last Updated

August 7, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

KR(2)