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

Completed

• Conditions: Human Microbiome

• Registration Number: NCT03157687
• Lead Sponsor: University of Erlangen-Nürnberg Medical School

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.

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2017-05-15
• Study First Submitted QC: 2017-05-15
• Study First Posted: 2017-05-17
• Status Verified: 2021-01
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Last Update Submitted: 2022-02-18
• Last Update Posted: 2022-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 117

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
bacterial composition	1 day	detection of bacterial families in stool and mucosa samples

Trial Locations

Locations (1)

University hospital Erlangen; 🇩🇪 Erlangen, Bavaria, Germany