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

NCT03157687 | Completed

• 1 other identifier: MicrobiomStudy
• Study Type: observational
• Target: 117
• Locations: 1 country
• Sites: 1

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.

Conditions

Human Microbiome

Outcome Measures

Primary Outcomes (1)

• bacterial composition

  detection of bacterial families in stool and mucosa samples

  1 day

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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)

You may not qualify if:

• other gastrointestinal disease, e.g. celiac disease, gastrointestinal tumors
• antibiotic treatment within 6 weeks before gastroscopy / colonoscopy

Sponsors & Collaborators

• University of Erlangen-Nürnberg Medical School: lead

Study Sites (1)

University hospital Erlangen

Erlangen, Bavaria, 91052, Germany

Location

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2017
• First Posted: May 17, 2017
• Study Start: June 1, 2016
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: February 21, 2022

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)