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Probiotics for Reduction of Infections With Clostridium Difficile in Critically Ill Patients

NCT01687543 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2017-10-05

No results posted yet for this study

Summary

Symptoms of Clostridium difficile infection is almost always induced as a complication to the use of antibiotics. Most ICU patients are given antibiotics.

Probiotics has the ability to improve conditions in the gut and it has been shown in some smaller studies that overgrowth of C. difficile can be reduced or prevented.

In this study the intention is to show with sufficient statistical power that a mixture of two otherwise well studied probiotic strains reduces or prevents the incidence of emerging colonisation with C. difficile in critical ill patients on antibiotics.

Half of the patients will be given a mixture of Lactobacillus plantarum 299 and Lactobacillus plantarum 299v twice daily and the rest a placebo mixture.

Rectal swabs or faeces will be analysed for C.difficile and its toxins and the incidence of new cases will be compared for the two groups.

White blood cells (WBC´s), C reactive protein (CRP), lactate, urea, and creatinine will be followed daily as well as antibiotics, corticosteroids and all acid reducing medication.

Nutrition, enteral and total, and bowel habits will be recorded.

Conditions

  • Clostridium Difficile Colonisation
  • Impact of Enteral Probiotics on Certain Lab Parameters

Interventions

DIETARY_SUPPLEMENT

L. plantarum 299 and L. plantarum 299v (+maltodextrin)

A suspension of Lactobacillus plantarum 299 and Lactobacillus plantarum 299v together with maltodextrin is distributed to the patients twice a day.

OTHER

Maltodextrin

A suspension of maltodextrin (as placebo control) is distributed to the patients twice a day.

Sponsors & Collaborators

  • Lund University

    collaborator OTHER

  • Region Skane

    lead OTHER

Principal Investigators

  • Bengt Klarin, MD, PhD · Lund University, Lund, Sweden

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2017-06-30
Completion
2017-10-01

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01687543 on ClinicalTrials.gov