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NCT Number: NCT02542579

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.

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Key information

Conditions

Microbial Colonization Communicable Diseases Digestive System Diseases Disease Attributes Dyspepsia Gastritis Gastroenteritis Gastrointestinal Diseases Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Stomach Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Konkuk University Medical Center, Seoul, South Korea

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

16S rRNA pyrosequencing analysis

Genetic

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

Primary outcomes

  1. Next generation sequencing analysis for microbiota

    Time frame: up to 6 months

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

Secondary outcomes

  1. Updated Sydney classification

    Time frame: up to 6 months

    0=none, 1=mild, 2= moderate, 3=marked infiltration

  2. Gastrointestinal endoscopy finding

    Time frame: up to 6 months

    Upper gastrointestinal endoscopy findings

  3. Gastrointestinal symptom and food intake score

    Time frame: up to 6 months

    Scoring system published in Neurogastroenterol Motil 2016;28:1401-1408

Sponsors and collaborators

Lead sponsor

Konkuk University Medical Center

Other

Registry information

Official study title

Composition of Gastric and Duodenal Microbiota in Dyspeptic Subjects

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Sep 7, 2015
Registry last updated
Aug 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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