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NCT04067271 Clinical Trial

LUEbeck Registry of Intensive Care Patients - Characterization of the Patients Intestinal MICROBIOME

ICU Patients Clinical Trial

— LUERIC-M  

Official title:
LUEbeck Registry of Intensive Care Patients - Characterization of the Patients Intestinal MICROBIOME

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04067271
Other study ID # 19-019
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 18, 2019
Est. completion date March 18, 2024

Study information
Verified date May 2022
Source University of Luebeck
Contact Tobias Graf, MD
Phone +49 451 500 75306
Email tobias.graf@uksh.de
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The purpose of the current study is to analyze the effects of ICU-care on changes in microbiome and the influence of intestinal microbiome changes on short-term and long-term morbidity and mortality of ICU patients.

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date March 18, 2024
Est. primary completion date March 18, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age =18 years - All patients receiving intensive medical care - A written informed consent from the patient or two independent doctors or legal guardians. Exclusion Criteria: - Age <18 years

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Analyze changes in intestinal microbiome
Descriptive Analysis

Locations
Country Name City State
Germany Medical Clinic II-UKSH Campus Lübeck Luebeck Schleswig-Holstein

Sponsors (1)
Lead Sponsor Collaborator
University of Luebeck

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Modification of the microbiome The modification of the microbiome using ribosomal 16 S DNA sequencing and clustering for Operational Taxonomic Units (OTU) and calculated Shannon Index Day 0
Secondary ICU intensive care unit stay Duration Day 0
Secondary Hospital stay Duration Month 12
Secondary Hospital stay Duration Month 6
Secondary Survival To discharge Month 6
Secondary Survival To discharge Month 12
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