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
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