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Clinical Trials/NCT03157687
NCT03157687
Completed
Not Applicable

Detection of Luminal and Mucosa-associated Microbiome in Healthy Controls vs. Local and Systemic Inflammation Under Mixed Diet

University of Erlangen-Nürnberg Medical School1 site in 1 country117 target enrollmentJune 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Human Microbiome
Sponsor
University of Erlangen-Nürnberg Medical School
Enrollment
117
Locations
1
Primary Endpoint
bacterial composition
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

This study should reveal differences in composition of luminal and mucosa-associated microbiome of the human gastrointestinal tract.Therefore bacterial species of different intestinal location sites (small intestine and colon) isolated of biopsies were compared to bacterial composition of stool samples. Additionally the bacterial composition of healthy persons, patients with inflammatory bowel disease and with liver disease (liver cirrhosis) will be compared to detect influence of local and systemic inflammation on microbiome.

Detailed Description

A dysbiosis of human gut microbiome is discussed in the pathogenesis of many disorders, also including gastrointestinal (e.g. inflammatory bowel disease, IBD) or liver diseases (e.g. liver cirrhosis) . A detailed analysis of intestinal bacterial patterns might reveal important findings for understanding disease pathogenesis. Thereby many studies only analysed the luminal microbiome of stool samples, whereas mucosa-associated bacteria have possibly a greater impact on human health and immune system . To determine the differences of luminal and mucosa-associated bacteria, stool and mucosa samples (via biopsies) will be collected. Thereby biopsies are taken of different intestinal locations (small intestine and colon) to detect variations along intestinal tract. An additional comparison of bacterial patterns in patients with chronic, local (IBD) and systemic inflammation (with liver cirrhosis) or without intestinal inflammations (healthy controls) should reveal the influence of microbiome on or by inflammation processes.

Registry
clinicaltrials.gov
Start Date
June 2016
End Date
December 31, 2021
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University of Erlangen-Nürnberg Medical School
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • healthy volunteers with indication for cancer screening without gastrointestinal symptoms
  • patients with inflammatory bowel disease (Crohn's disease and ulcerative colitis)
  • patients with indication for evaluation of liver transplantation (LTX)

Exclusion Criteria

  • other gastrointestinal disease, e.g. celiac disease, gastrointestinal tumors
  • antibiotic treatment within 6 weeks before gastroscopy / colonoscopy

Outcomes

Primary Outcomes

bacterial composition

Time Frame: 1 day

detection of bacterial families in stool and mucosa samples

Study Sites (1)

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