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NCT03157687 Clinical Trial

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

Human Microbiome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03157687
Other study ID # MicrobiomStudy
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 2016
Est. completion date December 31, 2021

Study information
Verified date January 2021
Source University of Erlangen-Nürnberg Medical School
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 117
Est. completion date December 31, 2021
Est. primary completion date December 31, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
Germany University hospital Erlangen Erlangen Bavaria

Sponsors (1)
Lead Sponsor Collaborator
University of Erlangen-Nürnberg Medical School

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary bacterial composition detection of bacterial families in stool and mucosa samples 1 day
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