Condition category
Infections and Infestations
Date applied
12/09/2007
Date assigned
17/09/2007
Last edited
17/09/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Bengt Klarin

ORCID ID

Contact details

Department of Anaesthesiology and Intensive Care
Lund University Hospital
Lund
SE-221 85
Sweden
+46 (0)46 17 19 49
Bengt.Klarin@med.lu.se

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

PROMAX 2

Study information

Scientific title

Acronym

Study hypothesis

By giving a probiotic bacterium with known ability to establish in the GI tract also in antibiotic-treated critically ill there will be a reduction of the incidence of Clostridium difficile in Intensive Care Unit (ICU) patients on antibiotics.

Ethics approval

Final ethical approval received on the 8th October 2001 from:
1. The Human Ethics Committee at Lund University (ref: LU 676-00)
2. The Human Ethics Committee at the University of Gothemburg (ref: Gbg M 123-01)

Study design

Randomised, double blind placebo controlled multi-centre study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Overgrowth of C. difficile in GI tract of antibiotic-treated ICU patients

Intervention

1. Active group receives a fermented oatmeal formula containing 8 x 10^8 colony forming units (cfu)/ml of Lactobacillus plantarum 299v
2. Control product contains no bacteria. Lactic acid has been added to reach the same pH as the active product

The patients are given six 100 ml doses of the study product at twelve hours intervals and then 50 ml twice a day as long as they are in the ICU.

Intervention type

Drug

Phase

Not Specified

Drug names

Lactobacillus plantarum 299v

Primary outcome measures

To study the impact of L plantarum 299v on emerging cases of C. difficile in ICU patients compared to those receiving a placebo product.

The primary outcome is validated over the whole period in the Intensive Care Unit and cultures from faeces are taken twice a week. Overgrowth or colonisation with C difficile can appear in the range from a few days to several weeks of antibiotic treatment and even after the medication has ended.

Secondary outcome measures

1. Study gut barrier function
2. Recovery rates of L plantarum 299v, and other effects on the gut microbiota
3. Systemic infections
4. Immune response, as White Blood Cell count (WBC), C-Reactive Protein (CRP) and cytokines (Tumour Necrotising Factor [TNF], Interleukin-1 [IL-1], Interleukin-6 [IL-6] and Interleukin-10 [IL-10])
5. Influence on metabolic parameters

Gut permeability is tested at inclusion day (day 1) and on day 4 so outcome is measured on study day 4. Faecal samples are taken at enrolment and then twice a week. Recovery of added bacteria are validated for the whole Length of Stay (LOS). Due to impaired function of the bowel in critically ill patients passage time through the gut varies so much that the whole LOS will be used to evaluate colonisation with L plantarum 299v. Microbiological cultures (as tests for systemic infections) are taken on clinical grounds or at least once a week and results are summarised for the whole LOS. Infectious, inflammatory and metabolic parameters are followed by daily blood tests throughout the stay in the ICU. Daily comparisons will be performed for the active treatment and placebo groups.

Overall trial start date

01/12/2001

Overall trial end date

15/09/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. 18 years or older
2. Critically ill, defined by a presumed need of intensive care for three days or more
3. Not have any known positive test for C. difficile within the week before enrolment
4. Be anticipated to tolerate enteral feeding
5. Starting within 24 hours from ICU admission

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

100

Participant exclusion criteria

1. Not be allergic to any of the components in the study product
2. If entereral feeding (including study product) is not started within 24 hours
3. Not be moribund

Recruitment start date

01/12/2001

Recruitment end date

15/09/2007

Locations

Countries of recruitment

Sweden

Trial participating centre

Department of Anaesthesiology and Intensive Care
Lund
SE-221 85
Sweden

Sponsor information

Organisation

Probi AB (Sweden)

Sponsor details

Ideon Gamma 1
Sölvegatan 41
Lund
SE-223 70
Sweden
+46 (0)46 286 89 20
probi@probi.se

Sponsor type

Industry

Website

http://www.probi.se/

Funders

Funder type

Industry

Funder name

Probi AB (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Region Skane (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Scandinavian Society for Antimicrobial Chemotherapy Foundation

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes