Probiotics for Prevention of Antibiotic Associated Diarrhea and Clostridium Difficile Associated Disease

Study Overview
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Brief Summary
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The study will evaluate if administration of probiotic Culturelle (Lactobacillus Rhamnosus GG) along with antibiotics can help decrease the occurrence of diarrhea caused by antibiotics as well as Clostridium difficile Diarrhea.

Detailed Description
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Inpatient adult males and females who are at least 18 years of age or older, undergoing treatment with antibiotics irrespective of indication and the type of antibiotics. The setting is an academic hospital.The patients are screened and potentially recruited upon initiation of antibiotic treatment regardless of indication for antibiotic prescription. The participants are patients being admitted to any inpatient units of the hospital for treatment with antibiotics. Exclusion criteria is: Diarrhea on admission or within the preceding week Reported recurrent diarrhea Bowel pathology that could result in diarrhea (including preexisting Inflammatory Bowel disease{IBD}, all forms for colitis or any other condition resulting in preexisting diarrhea) Intake of high risk antibiotics (clindamycin, cephalosporins, aminopenicillins→ well known to cause CDAD) and or more than two courses of other antibiotics in the past four weeks to exclude pre-existing diarrhea associated with antibiotic use Immunosuppression (Chronic steroid use, Active chemotherapy, Active radiotherapy, HIV or any other disorder resulting in a compromise in participants immune status) Bowel surgery causing liquid stools Regular probiotic intake before admission Lactose intolerance or intolerance to dairy products.

Official Title
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Probiotics for Prevention of Antibiotic Associated Diarrhea and Clostridium Difficile Associated Disease in Hospitalized Adults-A Double Blind Placebo Controlled Trial

Conditions
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Diarrhea

Intervention / Treatment
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* Dietary Supplement: Probiotics


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Inpatient adult males and females who are at least 18-89 years of age, undergoing treatment with antibiotics irrespective of indication and the type of antibiotics. Exclusion Criteria: Diarrhea on admission or within the preceding week Reported recurrent diarrhea Bowel pathology that could result in diarrhea (including preexisting Inflammatory Bowel disease{IBD}, all forms for colitis or any other condition resulting in preexisting diarrhea) Intake of high risk antibiotics (clindamycin, cephalosporins, aminopenicillins→ well known to cause CDAD) and or more than two courses of other antibiotics in the past four weeks to exclude pre-existing diarrhea associated with antibiotic use Immunosuppression (Chronic steroid use, Active chemotherapy, Active radiotherapy, HIV or any other disorder resulting in a compromise in participants immune status) Bowel surgery causing liquid stools Regular probiotic intake before admission Lactose intolerance or intolerance to dairy products

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo capsules | Dietary Supplement: Probiotics<br>* Randomized to receive probiotics or placebo<br>* Other names: Lactobacillus Rhamnosus GG 10 billion cfu bid;|
| Experimental: Probiotics<br>Lactobacillus Rhamnosus GG 10 billion cfu BID | Dietary Supplement: Probiotics<br>* Randomized to receive probiotics or placebo<br>* Other names: Lactobacillus Rhamnosus GG 10 billion cfu bid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diarrhea | Diarrhea associated with antibiotics | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability of probiotics | Patient experience with use of probiotics | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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antibiotics, diarrhea, c diff, Hospitalized patients