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

Sponsor
University of Erlangen-Nürnberg Medical School (Other)
Overall Status
Completed
CT.gov ID
NCT03157687
Collaborator
(none)
117
Enrollment
1
Location
67
Actual Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    117 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Detection of Luminal and Mucosa-associated Microbiome in Healthy Controls vs. Local and Systemic Inflammation Under Mixed Diet
    Actual Study Start Date :
    Jun 1, 2016
    Actual Primary Completion Date :
    Dec 31, 2021
    Actual Study Completion Date :
    Dec 31, 2021

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. bacterial composition [1 day]

      detection of bacterial families in stool and mucosa samples

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University hospital Erlangen Erlangen Bavaria Germany 91052

    Sponsors and Collaborators

    • University of Erlangen-Nürnberg Medical School

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Erlangen-Nürnberg Medical School
    ClinicalTrials.gov Identifier:
    NCT03157687
    Other Study ID Numbers:
    • MicrobiomStudy
    First Posted:
    May 17, 2017
    Last Update Posted:
    Feb 21, 2022
    Last Verified:
    Jan 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Inflammation

    Study Results

    No Results Posted as of Feb 21, 2022