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Status unknownNCT04067271LUERIC-MUpdated May 18, 2022

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

An observational study in ICU Patients, sponsored by University of Luebeck. Status unknown at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-18.

Sponsored by University of Luebeck · Observational

The sponsor has not verified this record recently (last verified May 2022), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • ICU Patients
03

In context

Lead sponsor

University of Luebeck is the lead sponsor of 74 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients who receive treatment on ICU.

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

Exclusion Criteria:

  • Age \<18 years
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)
Target follow-up
1 Year
Patient registry
Yes

Interventions

  • OtherAnalyze changes in intestinal microbiome

    Descriptive Analysis

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Day 0

Secondary outcomes

  1. ICU intensive care unit stay

    Duration

    Time frame: Day 0

  2. Hospital stay

    Duration

    Time frame: Month 12

  3. Hospital stay

    Duration

    Time frame: Month 6

  4. Survival

    To discharge

    Time frame: Month 6

  5. Survival

    To discharge

    Time frame: Month 12

07

Study locations

1 of 1 sites recruiting
  • Medical Clinic II-UKSH Campus Lübeck
    Luebeck, Schleswig-Holstein 23562, Germany
    • Tobias Graf, MD · Contact
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 18, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04067271
Lead sponsor
University of Luebeck
Responsible party
Dr. med. Tobias Graf (Principal Investigator, University of Luebeck) — Principal investigator
First posted
Aug 26, 2019
Start date
Mar 18, 2019
Primary completion
Mar 18, 2024 (estimated)
Completion
Mar 18, 2024 (estimated)
Last update
May 18, 2022

Study contacts

Tobias Graf, MD
Contact
tobias.graf@uksh.de
+49 451 500 75306
Roza Meyer-Saraei, PhD
Contact
roza.meyer-saraei@uksh.de
+49 451 500 44542

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2022. You cannot join it, but the record below documents what was studied.

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