CDI Synbiotic Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effectiveness of a Synbiotic Mixture (Inulin, Lactobacillus Rhamnosus (LGG®), Lactobacillus Acidophilus (LA-5®), Lactobacillus Paracasei, and Bifidobacterium Lactis (BB-12®)), on Decreasing Recurrence of Clostridium Difficile Associated Diarrhea- a , Randomized, Placebo-controlled Study With 4 Weeks Intervention

Conditions
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Clostridium Difficile Infection

Intervention / Treatment
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* Dietary Supplement: Synbiotic mixture
* Other: Placebo comparator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients diagnosed with primary CDI Treatment with Vancomycin Subjects over 18 years of age Signed informed consent Exclusion Criteria: Chemotherapy within two months and an absolute neutrophil count of < 1000 neutrophiles/mm3 Acute leukemia Serious immunodeficiency Pancreatitis Planned or recent intraabdominal operation within a time window of 14 days Terminal disease with expected survival time < 3 month Probiotic consumption within two weeks prior enrollment Pregnant or lactating women A history of inflammatory or irritable bowel disease Colectomy and cirrhosis Septicemia Toxic megacolon

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: probiotic arm<br>inulin, 15 g Lactobacillus rhamnosus (LGG®) Lactobacillus acidophilus (LA-5®) Lactobacillus paracasei (L. casei 431®) Bifidobacterium lactis (BB-12®), Total cell counts 150 billion/day | Dietary Supplement: Synbiotic mixture<br>* A synbiotic mixture consisting of four probiotic strains and inulin (a prebiotic)<br>|
| Placebo Comparator: placebo arm<br>placebo powder, 15 g | Other: Placebo comparator<br>* Placebo powder<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduced recurrence of C. difficile-associated diarrhoea (CDAD) after 8 weeks | telephone questionnaire with patient at end of trial as well as examination of each patient's medical record | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| toxin A and B levels measured by qPCR |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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probiotics, prebiotics, synbiotics