Clostridium Difficile Infection
Conditions
Keywords
probiotics, prebiotics, synbiotics
Brief summary
The investigators hypothesize that treatment with a synbiotic mixture consisting of inulin Lactobacillus rhamnosus (LGG®), Lactobacillus acidophilus (LA-5®), Lactobacillus paracasei (L. casei 431®) and Bifidobacterium lactis (BB-12®) can reduce the number of C. difficile recurrences significantly.
Detailed description
Probiotics have been tested for their efficacy in preventing infection with C. difficile after antibiotic exposure. Some of the most effective probiotics tested Lactobacillus rhamnosus (LGG®), Lactobacillus acidophilus (LA-5®), Lactobacillus paracasei (L. casei 431®) and Bifidobacterium lactis (BB-12®). However, most studies have focused on prevention of the first incidence of C. difficile infection rather than prevention of re-infection with C. difficile. Recurrence rates of C. difficile infection (CDI) among hospitalized patients are 15-25% - either as relapses caused by the original organism or re-infection following treatment. The potential of probiotics in preventing re-infection is less studied in these patients. Further, prebiotics which are carbohydrates only metabolized by beneficial bacteria have gained much attention the recent years for their health benefits through stimulating growth of specific types of bacteria in the gut, and recent data from mouse studies show that the prebiotic inulin can eliminate C. difficile growth, but the use of prebiotics in relation to C. difficile elimination has yet to be proven in humans. The investigators hypothesize that treatment with a synbiotic mixture consisting of inulin Lactobacillus rhamnosus (LGG®), Lactobacillus acidophilus (LA-5®), Lactobacillus paracasei (L. casei 431®) and Bifidobacterium lactis (BB-12®) can reduce the number of C. difficile recurrences significantly.
Interventions
DIETARY_SUPPLEMENTSynbiotic mixture
A synbiotic mixture consisting of four probiotic strains and inulin (a prebiotic)
OTHERPlacebo comparator
Placebo powder
Sponsors
Hvidovre University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Patients diagnosed with primary CDI * Treatment with Vancomycin * Subjects over 18 years of age * Signed informed consent
Exclusion criteria
1. Chemotherapy within two months and an absolute neutrophil count of \< 1000 neutrophiles/mm3 2. Acute leukemia 3. Serious immunodeficiency 4. Pancreatitis 5. Planned or recent intraabdominal operation within a time window of 14 days 6. Terminal disease with expected survival time \< 3 month 7. Probiotic consumption within two weeks prior enrollment 8. Pregnant or lactating women 9. A history of inflammatory or irritable bowel disease 10. Colectomy and cirrhosis 11. Septicemia 12. Toxic megacolon
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduced recurrence of C. difficile-associated diarrhoea (CDAD) after 8 weeks | 1 year | telephone questionnaire with patient at end of trial as well as examination of each patient's medical record |
Secondary
| Measure | Time frame |
|---|---|
| toxin A and B levels measured by qPCR | 1 year |
Countries
Denmark
Contacts
Primary ContactAndreas M Petersen
Backup ContactMaria IC Rubin
Outcome results
None listed