Can Lactobacillus plantarum 299v in fermented oat meal gruel prevent overgrowth of Clostridium difficile in the Gastrointestinal (GI) tract in antibiotic treated critically ill patients? [Kan Lactobacillus Plantarum 299v i fermenterad havrevälling motverka överväxt av Clostridium Difficile i magtarmkanalen hos antibiotikabehandlade kritiskt sjuka patienter?]
| ISRCTN | ISRCTN85655545 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN85655545 |
| Secondary identifying numbers | PROMAX 2 |
- Submission date
- 12/09/2007
- Registration date
- 17/09/2007
- Last edited
- 02/09/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Bengt Klarin
Scientific
Scientific
Department of Anaesthesiology and Intensive Care
Lund University Hospital
Lund
SE-221 85
Sweden
| Phone | +46 (0)46 17 19 49 |
|---|---|
| Bengt.Klarin@med.lu.se |
Study information
| Study design | Randomised, double blind placebo controlled multi-centre study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Can Lactobacillus plantarum 299v in fermented oat meal gruel prevent overgrowth of Clostridium difficile in the Gastrointestinal (GI) tract in antibiotic treated critically ill patients? [Kan Lactobacillus Plantarum 299v i fermenterad havrevälling motverka överväxt av Clostridium Difficile i magtarmkanalen hos antibiotikabehandlade kritiskt sjuka patienter?] |
| Study objectives | 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(s) | 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) |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Lactobacillus plantarum 299v |
| Primary outcome measure | 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 study start date | 01/12/2001 |
| Completion date | 15/09/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 100 |
| Total final enrolment | 44 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/12/2001 |
| Date of final enrolment | 15/09/2007 |
Locations
Countries of recruitment
- Sweden
Study participating centre
Department of Anaesthesiology and Intensive Care
Lund
SE-221 85
Sweden
SE-221 85
Sweden
Sponsor information
Probi AB (Sweden)
Industry
Industry
Ideon Gamma 1
Sölvegatan 41
Lund
SE-223 70
Sweden
| Phone | +46 (0)46 286 89 20 |
|---|---|
| probi@probi.se | |
| Website | http://www.probi.se/ |
"ROR" |
https://ror.org/03yf63872 |
Funders
Funder type
Industry
Probi AB (Sweden)
No information available
Region Skane (Sweden)
No information available
The Scandinavian Society for Antimicrobial Chemotherapy Foundation
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/09/2008 | 02/09/2021 | Yes | No |
Editorial Notes
02/09/2021: Publication reference and total final enrolment added.
