Gastric and Duodenal Microbiota in Dyspeptic Subjects

Microbial Colonization Clinical Trial

Official title:

Composition of Gastric and Duodenal Microbiota in Dyspeptic Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02542579
• Other study ID #: KUH1010691
• Status: Completed
• Start date: June 2016
• Est. completion date: August 2018

Study information

• Verified date: August 2018
• Source: Konkuk University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: August 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Gastritis
• Infection
• Microbial Colonization

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Konkuk University Medical Center	Seoul
Korea, Republic of	Konkuk University Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Konkuk University Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (3)

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. — View Citation

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):513-8. doi: 10.1099/jmm.0.000050. Epub 2015 Mar 9. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Next generation sequencing analysis for microbiota	16S rRNA pyrosequencing analysis findings of the gastric and duodenal biopsies	up to 6 months
Secondary	Updated Sydney classification	0=none, 1=mild, 2= moderate, 3=marked infiltration	up to 6 months
Secondary	Gastrointestinal endoscopy finding	Upper gastrointestinal endoscopy findings	up to 6 months
Secondary	Gastrointestinal symptom and food intake score	Scoring system published in Neurogastroenterol Motil 2016;28:1401-1408	up to 6 months