Pseudomonas InfectionsNCT00621803
Lcr35 / ICU / P. Aeruginosa
A study testing Probiotic Lactobacillus casei rhamnosus (Lcr35) in people with Pseudomonas Infections, run by University Hospital, Clermont-Ferrand.
Trial summary
Preventing carriage of potentially pathogenic micro-organisms from the aerodigestive tract is an infection control strategy used to reduce the occurrence of nosocomial infections - including ventilator-assisted pneumonia - in intensive care units. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pseudomonas Infections
- What is being tested?
- Probiotic Lactobacillus casei rhamnosus (Lcr35)
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- Mar 2003to Oct 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- more than 18 years old
- length of stay longer than 48h
- with a nasogastric feeding tube
Who cannot join
- - less than 18 years old
- length of stay < 48h
- immunosuppression
- absolute neutrophile count < 500/mm3
- gastro-intestinal bleeding
- contraindicated enteral feeding
- positive P. aeruginosa gastric aspirates or respiratory tract specimens during the first four days after hospital admission
About this study
Official title: Prevention of Gastric Colonisation by Antibiotic Resistant Pseudomonas Aeruginosa Strains Using Oral Probiotic in ICU-Patients
Preventing carriage of potentially pathogenic micro-organisms from the aerodigestive tract is an infection control strategy used to reduce the occurrence of nosocomial infections - including ventilator-assisted pneumonia - in intensive care units. The use of antibiotics is controversial and can lead to adverse effect such as the selection of highly resistant pathogens. The purpose of this study was to investigate the effect of oral administration of a probiotic strain, Lactobacillus, on gastric and respiratory tract colonisation/infection by Pseudomonas aeruginosa strains, according to the concept that an indigenous flora has a protective effect against secondary colonisation.
Read the detailed description
In this prospective double-blind randomised study, ICU patients receive twice a day either an oral dose of Lactobacillus casei rhamnosus, the available pharmaceutical form, or a placebo. Digestive tract carriage of Pseudomonas aeruginosa is monitored by cultures of gastric aspirates. The occurrence of respiratory tract colonisations / infections is monitored throughout the study. Evaluation criteria are the delay and the rates of gastric P. aeruginosa colonisation and respiratory tract infection or colonisation. Chi-square or two tailed Fisher exact test are used for comparing qualitative variables and Student's t-test or mann-Whitney test for quantitatives variables. The mean of non-acquisition expectancy (NAE), length of stay without P. aeruginosa acquisition, was calculated and P. aeruginosa non-colonized patient rates were estimated and the two groups compared with regard to survival curves from grouped data using the Kaplan Meier method and the Logrank test. Variables with a P. value ≤0.15 in the univariate analysis were included in a logistic regression and a Cox regression model for multivariate analysis.
- Conditions
- Pseudomonas Infections
- Being tested
- Probiotic Lactobacillus casei rhamnosus (Lcr35)
- Keywords
- Probiotic, Pseudomonas aeruginosa, Gastric colonization, Respiratory tract colonization, Ventilator aquired pneumoniae, determine the effect of oral administration of this probiotic on gastric and respiratory tract colonisation/infection by P. aeruginosa
- Medical subject headings
- Pseudomonas Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic Lactobacillus casei rhamnosus (Lcr35)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Delay in P.aeruginosa colonisation
Secondary outcomes (1)
Delay of respiratory tract infection or colonisation due to P.aeruginosa. Persistance of L.casei rhamnosus in to the stomach
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2008 (estimated)
- Study startMar 2003
- Primary completionOct 2004 (estimated)
- Study completionOct 2005 (estimated)
Why it stopped: Recruiting or enrolling participants has halted and will not resume
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pseudomonas InfectionsStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Université d'Auvergne
- Investigators
- Christophe De Champs, MD PhD, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00621803
- Sponsor's protocol ID
- CHU-0029
- Other IDs
- AFSSAPS 1220/CM/FE02
- Status last verified
- Feb 2008
- First submitted
- 11 Feb 2008
- Last updated
- 22 Feb 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Gastric Colonisation by Antibiotic Resistant Pseudomonas Aeruginosa Strains Using Oral Probiotic in ICU-Patients
- ClinicalTrials.gov ID
- NCT00621803
- Acronym / sponsor ID
- CHU-0029
- Conditions
- Pseudomonas Infections
- Keywords
- Probiotic, Pseudomonas aeruginosa, Gastric colonization, Respiratory tract colonization, Ventilator aquired pneumoniae, determine the effect of oral administration of this probiotic on gastric and respiratory tract colonisation/infection by P. aeruginosa
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruiting or enrolling participants has halted and will not resume
- Enrolment
- 400 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Université d'Auvergne
- Study start
- Mar 2003
- Primary completion
- Oct 2004 (estimated)
- Study completion
- Oct 2005 (estimated)
- First posted
- 22 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Preventing carriage of potentially pathogenic micro-organisms from the aerodigestive tract is an infection control strategy used to reduce the occurrence of nosocomial infections - including ventilator-assisted pneumonia - in intensive care units. The use of antibiotics is controversial and can lead to adverse effect such as the selection of highly resistant pathogens. The purpose of this study was to investigate the effect of oral administration of a probiotic strain, Lactobacillus, on gastric and respiratory tract colonisation/infection by Pseudomonas aeruginosa strains, according to the concept that an indigenous flora has a protective effect against secondary colonisation.
Detailed description
In this prospective double-blind randomised study, ICU patients receive twice a day either an oral dose of Lactobacillus casei rhamnosus, the available pharmaceutical form, or a placebo. Digestive tract carriage of Pseudomonas aeruginosa is monitored by cultures of gastric aspirates. The occurrence of respiratory tract colonisations / infections is monitored throughout the study. Evaluation criteria are the delay and the rates of gastric P. aeruginosa colonisation and respiratory tract infection or colonisation. Chi-square or two tailed Fisher exact test are used for comparing qualitative variables and Student's t-test or mann-Whitney test for quantitatives variables. The mean of non-acquisition expectancy (NAE), length of stay without P. aeruginosa acquisition, was calculated and P. aeruginosa non-colonized patient rates were estimated and the two groups compared with regard to survival curves from grouped data using the Kaplan Meier method and the Logrank test. Variables with a P. value ≤0.15 in the univariate analysis were included in a logistic regression and a Cox regression model for multivariate analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- more than 18 years old
- length of stay longer than 48h
- with a nasogastric feeding tube
Key exclusion criteria (7 listed)
- - less than 18 years old
- length of stay < 48h
- immunosuppression
- absolute neutrophile count < 500/mm3
- gastro-intestinal bleeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Probiotic Lactobacillus casei rhamnosus (Lcr35) | Drug | – |
Primary outcome
Delay in P.aeruginosa colonisation
1 secondary outcome
Delay of respiratory tract infection or colonisation due to P.aeruginosa. Persistance of L.casei rhamnosus in to the stomach
Results and safety
The study was stopped early (reason given: Recruiting or enrolling participants has halted and will not resume). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christophe De Champs, MD PhD principal investigator
University Hospital, Clermont-Ferrand
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic Lactobacillus casei rhamnosus (Lcr35) in people with Pseudomonas Infections, run by University Hospital, Clermont-Ferrand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Feb 2008. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Recruiting or enrolling participants has halted and will not resume). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delay in P.aeruginosa colonisation. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2008; AzTrials last refreshed its copy on 6 Nov 2026.