NCT02469571

Brief Summary

Background Sepsis is a common disease leading to high morbidity and mortality. Gut microbiota and/or gut permeability may play a crucial role in the development of organ dysfunction. Hypothesis The ingestion of a multispecies probiotic in early sepsis is able to modulate gut microbiota and/or gut permeability.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable sepsis

Timeline
Completed

Started Sep 2015

Typical duration for not_applicable sepsis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 3, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 11, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2016

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

March 29, 2018

Status Verified

March 1, 2018

Enrollment Period

11 months

First QC Date

June 3, 2015

Last Update Submit

March 27, 2018

Conditions

Sepsis

Outcome Measures

Primary Outcomes (1)

  • Gut microbiota composition

    next generation sequencing

    4 weeks

Secondary Outcomes (4)

  • gut permeability

    4 weeks

  • endotoxin

    4 weeks

  • soluble sepsis markers

    4 weeks

  • neutrophil function

    4 weeks

Study Arms (2)

Probiotic

ACTIVE COMPARATOR

5 g of Winclove-607 containing Bifidobacterium bifidum W23, Bifidobacterium lactis W51, Enterococcus faecium W54, Lactobacillus acidophilus W37, Lactobacillus acidophilus W55, Lactobacillus paracasei W20, Lactobacillus plantarum W1, Lactobacillus plantarum W62, Lactobacillus rhamnosus W71, Lactobacillus salivarius W24 at a concentration of 1.1 x 109 cfu/g twice daily for the 4 weeks

Dietary Supplement: Winclove 607

Placebo

PLACEBO COMPARATOR

a similar looking and tasting placebo without bacteria once daily for 4 weeks

Dietary Supplement: Placebo

Interventions

Winclove 607DIETARY_SUPPLEMENT

multispecies probiotic

Probiotic
PlaceboDIETARY_SUPPLEMENT

Placebo

Placebo

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Internal Medicine, Medical University of Graz

Graz, 8036, Austria

Location

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Vanessa Stadlbauer-Köllner, MD

    Medical University of Graz

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2015

First Posted

June 11, 2015

Study Start

September 1, 2015

Primary Completion

July 31, 2016

Study Completion

March 1, 2018

Last Updated

March 29, 2018

Record last verified: 2018-03

Locations

AU(1)