Modulation of Gut Microbiota in Early Sepsis: A Pilot Study

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02469571
• Date of registration: 03/06/2015
• Prospective Registration: Yes
• Primary sponsor: Medical University of Graz
• Public title: Modulation of Gut Microbiota in Early Sepsis: A Pilot Study MGM-sepsis
• Scientific title: Modulation of Gut Microbiota in Early Sepsis: A Pilot Study
• Date of first enrolment: September 1, 2015
• Target sample size: 15
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02469571
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Austria

Contacts

• Name: Vanessa Stadlbauer-Köllner, MD
• Affiliation: Medical University of Graz

Key inclusion & exclusion criteria

Inclusion Criteria:

- Participant is willing and able to give informed consent for participation in the
study.

- Age above 18 years

- Sepsis as defined by the presence of a systemic inflammatory response syndrome (2 out
of the four: elevated heart rate (tachycardia) >90 beats per minute at rest; body
temperature either high (>100.4 F or 38 C) or low (<96.8 F or 36 C); increased
respiratory rate of >20 breaths per minute or a reduced partial pressure of carbon
dioxide (PaCO2) in arterial blood level; abnormal white blood cell count (>12,000
cells/µL or <4,000 cells/µL or >10% bands [an immature type of white blood cell]) and
a known or suspected infection

- Blood cultures ordered by the attending physician

Exclusion Criteria:

- Severe sepsis or septic shock as defined by the Surviving Sepsis Guidelines [1]

- Admission to any intensive care unit or intermediate care unit for any reason

- soluble urokinase plasminogen activator receptor (sUPAR) level at admission >9.15
ng/mL [19]

- Positive beta-D-glycan test

- Patients receiving (par)enteral nutrition

- Presence or suspicion of acute pancreatitis

- Inability to understand and sign an informed consent

- Pregnancy or women of childbearing age without adequate contraception

- Women who are breast-feeding

- Known malignancy or any other condition or circumstance, which, in the opinion of the
investigator, would affect the patient's ability to participate in the protocol



Age minimum: 18 Years
Age maximum: 100 Years
Gender: All

Health Condition(s) or Problem(s) studied

Sepsis

Intervention(s)

Dietary Supplement: Winclove 607

Dietary Supplement: Placebo

Primary Outcome(s)

Gut microbiota composition [Time Frame: 4 weeks]

Secondary Outcome(s)

gut permeability [Time Frame: 4 weeks]

soluble sepsis markers [Time Frame: 4 weeks]

endotoxin [Time Frame: 4 weeks]

neutrophil function [Time Frame: 4 weeks]

Secondary ID(s)

26-496 ex 13/14

Source(s) of Monetary Support

Please refer to primary and secondary sponsors