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OpenTrials
Completed

NCT Number: NCT03157687

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University hospital Erlangen

Erlangen, Bavaria, 91052, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Primary outcomes

  1. bacterial composition

    Time frame: 1 day

    detection of bacterial families in stool and mucosa samples

Sponsors and collaborators

Lead sponsor

University of Erlangen-Nürnberg Medical School

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
May 17, 2017
Registry last updated
Feb 21, 2022

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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