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

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

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.

Study Overview

• Status: Completed
• Conditions: Human 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 Type: Observational
• Enrollment (Actual): 117

Contacts and Locations

Study Locations

• Germany
  • Bavaria
    • Erlangen, Bavaria, Germany, 91052
      • University Hospital Erlangen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

healthy controls patients with inflammatory bowel disease patients with liver disease (liver cirrhoses) and indication for LTX-evaluation

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Healthy controls; Blood sampling for nutrition and inflammatory status; Stool sampling before preventive gastroscopy and colonoscopy; Questionnaires about general health, gastrointestinal symptoms and 3-day food record; Collection of biopsies in duodenum during gastroscopy; Collection of biopsies in terminal ileum, cecum, colon ascendens, sigma
Inflammatory bowel disease (IBD); Blood sampling for nutrition and inflammatory status; Stool sampling before indicated gastroscopy and colonoscopy; Questionnaires about general health, gastrointestinal symptoms and 3-day food record; Collection of biopsies in duodenum during gastroscopy; Collection of biopsies in terminal ileum, cecum, colon ascendens, sigma
Liver transplantation recipient (LTX); Blood sampling for nutrition and inflammatory status; Stool sampling before indicated gastroscopy and colonoscopy for evaluation of liver transplantation (LTX); Questionnaires about general health, gastrointestinal symptoms and 3-day food record; Collection of biopsies in duodenum during gastroscopy; Collection of biopsies in terminal ileum, cecum, colon ascendens, sigma

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
bacterial composition	detection of bacterial families in stool and mucosa samples	1 day

Collaborators and Investigators

• Sponsor: University of Erlangen-Nürnberg Medical School

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: May 15, 2017
• First Submitted That Met QC Criteria: May 15, 2017
• First Posted (Actual): May 17, 2017

Study Record Updates

• Last Update Posted (Actual): February 21, 2022
• Last Update Submitted That Met QC Criteria: February 18, 2022
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation
• Other Study ID Numbers: MicrobiomStudy

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No