Microbial ColonizationNCT02542579
Gastric and Duodenal Microbiota in Dyspeptic Subjects
An observational study of Microbial Colonization and Gastritis, run by Konkuk University Medical Center at 2 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Microbial Colonization, Gastritis
- What is being tested?
- 16S rRNA pyrosequencing analysis
- How many people
- 98 participants
- Where
- 2 sitesSouth Korea
- Study dates
- Jun 2016to Aug 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Dyspeptic subjects for analysis
Who may be able to join
- Dyspeptic subjects who visited for evaluation including upper gastrointestinal endoscopy and biopsies
- Age >20 years old
Who cannot join
- Underlying disease(s) that requires managements
- Recent intake of drug(s)
- History of gastrectomy
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Konkuk University Medical Center
Seoul, 05030
Konkuk University Medical Center
Seoul, 143729
About this study
Official title: Composition of Gastric and Duodenal Microbiota in Dyspeptic Subjects
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.
Read the 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
- Being tested
- 16S rRNA pyrosequencing analysis
- Keywords
- Helicobacter pylori, Dyspepsia
- Medical subject headings
- Communicable Diseases, Gastritis, Dyspepsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
16S rRNA pyrosequencing analysisGenetic
Next generation sequencing analysis will be done for 16S rRNA V1,2 hypervariable regions at Biocore (Seoul, Korea).
| Study group | Role | What they receive |
|---|---|---|
| Subjects for pyrosequencing analysis | Dyspeptic subjects who visited for evaluation and agreed on 16S rRNA pyrosequencing analysis Receives: Genetic: 16S rRNA pyrosequencing analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Next generation sequencing analysis for microbiota
16S rRNA pyrosequencing analysis findings of the gastric and duodenal biopsies
Measured: up to 6 months
Secondary outcomes (3)
Updated Sydney classification
0=none, 1=mild, 2= moderate, 3=marked infiltration
Measured: up to 6 months
Gastrointestinal endoscopy finding
Upper gastrointestinal endoscopy findings
Measured: up to 6 months
Gastrointestinal symptom and food intake score
Scoring system published in Neurogastroenterol Motil 2016;28:1401-1408
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2015 (estimated)
- Study startJun 2016
- Primary completionMar 2018
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Microbial ColonizationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konkuk University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sun-Young Lee, Konkuk University Medical Center
- Investigators
- Sun-Young Lee, M.D., Ph.D., Principal investigator, Konkuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02542579
- Sponsor's protocol ID
- KUH1010691
- Status last verified
- Aug 2018
- First submitted
- 23 Aug 2015
- Last updated
- 7 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 25752852Lee 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.
PubMed 25257099Lee 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.
PubMed 22098099
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Composition of Gastric and Duodenal Microbiota in Dyspeptic Subjects
- ClinicalTrials.gov ID
- NCT02542579
- Acronym / sponsor ID
- KUH1010691
- Conditions
- Microbial Colonization, Gastritis
- Keywords
- Helicobacter pylori, Dyspepsia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Konkuk University Medical CenterUniversity, hospital or other
- Study start
- Jun 2016 (actual)
- Primary completion
- Mar 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 7 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects for pyrosequencing analysis | – | Genetic: 16S rRNA pyrosequencing analysisDyspeptic subjects who visited for evaluation and agreed on 16S rRNA pyrosequencing analysis |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Dyspeptic subjects for analysis
Key inclusion criteria (2 listed)
- Dyspeptic subjects who visited for evaluation including upper gastrointestinal endoscopy and biopsies
- Age >20 years old
Key exclusion criteria (3 listed)
- Underlying disease(s) that requires managements
- Recent intake of drug(s)
- History of gastrectomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 16S rRNA pyrosequencing analysisNext generation sequencing analysis will be done for 16S rRNA V1,2 hypervariable regions at Biocore (Seoul, Korea). | Genetic | Subjects for pyrosequencing analysis |
Primary outcome
Next generation sequencing analysis for microbiota
Time frame: up to 6 months
16S rRNA pyrosequencing analysis findings of the gastric and duodenal biopsies
3 secondary outcomes
Updated Sydney classification
Time frame: up to 6 months
Gastrointestinal endoscopy finding
Time frame: up to 6 months
Gastrointestinal symptom and food intake score
Time frame: up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2018.
- Background: PubMed 25752852Lee 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.
- Background: PubMed 25257099Lee 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.
- Background: PubMed 22098099Lee 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sun-Young Lee, M.D., Ph.D. principal investigator
Konkuk University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Microbial Colonization and Gastritis, run by Konkuk University Medical Center at 2 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Next generation sequencing analysis for microbiota (time frame: up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02542579, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2018.