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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

117 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-06-30

Study Completion Date

2021-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Gut Microbiome in Inflammatory Bowel Disease

NCT03589183

Inflammatory Bowel Diseases Ulcerative Colitis Crohn Disease

RECRUITING

Elemental Diet and Gut Microbiome

NCT05978973

Irritable Bowel Syndrome

COMPLETED NA

Microbiota and Related Metabolome in Omnivore, Vegetarian or Vegan Diets

NCT02118857

Diet and Human Microbiota

UNKNOWN

The Effect of Dietary Intervention on Symptoms, Epigenetics, and Gut Microbiota in IBS

NCT03306381

IBS - Irritable Bowel Syndrome

COMPLETED NA

Significance of Synbiotics on Inflammation and Proliferation of Colonic Mucosa

NCT01534572

Inflammation

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Human Microbiome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

No interventions assigned to this group

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

No interventions assigned to this group

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

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)