Lactobacillus Reuteri in the Prevention of Antibiotic Associated-diarrhea and Clostridium Difficile

Study Overview
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Brief Summary
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The purpose of this study is to find whether Lactobacillus reuteri prevents antibiotic-associated diarrhea and related Clostridium difficile infections. Subjects will be admitted from the University Hospitals Case Medical Center. They will be randomly assigned to an intervention group receiving L. reuteri or a placebo. Supplementation will occur during antibiotic treatment and for an additional 7 days after cessation of treatment. Data collection will occur at baseline, end of antibiotic use, 7 days after antibiotic cessation, and 21 days after antibiotic cessation. Primary data includes diarrhea instances. Secondary data includes severity of diarrhea, presence of C. difficile toxins, and presence of other GI symptoms.

Detailed Description
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The data being measured for this study include: Primary outcome = incidence of diarrhea during and after treatment with antibiotics. An episode of diarrhea is defined as the discrete period between the time when stool output meets or exceeds three soft and unformed or watery bowel movements to the time when formed stools return, which must be at least 48 hours later. Secondary variables: severity of diarrhea measured as the discrete period between the time when stool output meets or exceeds 3 soft and unformed or watery bowel movements to the time when formed stools return. frequency of stool samples positive for C. Difficile toxin A or B at baseline, when presenting with diarrhea during the study period, and at the follow-up 21 days post-antibiotic-treatment to detect possible clearance of C. Difficile, in patients ingesting L. reuteri versus placebo. frequencies of other gastrointestinal symptoms at 1, 2, and 4 weeks, in the L. reuteri group versus placebo and assessed by the validated Gastrointestinal Symptom Rating Score.

Official Title
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Efficacy and Safety of the Probiotic Lactobacillus Reuteri in the Prevention of Antibiotic Associated-diarrhea and Clostridium Difficile Related Infections in Hospitalized Adult Patients

Conditions
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Antibiotic-associated Diarrhea, Clostridium Difficile

Intervention / Treatment
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* Dietary Supplement: Lactobacillus reuteri


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Receiving antibiotics for not more than 48 hours prior to enrollment and free from diarrhea able to understand and sign informed consent and HIPPA available throughout the study period subjects should have the mental ability to understand and willingness to fulfill all the details of the protocol Exclusion Criteria: three or more soft and unformed or watery stools per day at admission receiving chemotherapy or radiation therapy diagnosis of inflammatory bowel disease NPO without PO meds neutropenia (an absolute neutrophil count (ANC) of less than 1500/microL) HIV positive with a CD4+ T-lymphocyte count <400 per mcL blood requiring care in an intensive care unit status-post bowel resection during hospitalization patient's receiving antibiotics four weeks prior to hospitalization patient with severe life threatening illness or immunocompromised pregnancy

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| Experimental: L. reuteri<br> | Dietary Supplement: Lactobacillus reuteri<br>* One chewable tablet of 1E8 CFU L. reuteri, once per day<br>* Other names: BioGaia, Probiotic Chewable Tablets;|
| Placebo Comparator: Identical Placebo<br> | Dietary Supplement: Lactobacillus reuteri<br>* One chewable tablet of 1E8 CFU L. reuteri, once per day<br>* Other names: BioGaia, Probiotic Chewable Tablets;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| diarrhea | Instances of diarrhea | 28+ days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of diarrhea | measured as the discrete period between the time when stool output meets or exceeds three soft and unformed or watery bowel movements to the time when formed stools return. | 28+ days | 
| Frequency of stool samples positive for C. difficile toxin A and B | Frequency of stool samples positive for C. difficile toxin A and B at baseline, when presenting with diarrhea during the study period, and at the follow-up 21 days post antibiotic-treatment to detect possible clearance of C. difficile, in patients ingesting L. reuteri versus placebo. | baseline, when presenting with diarrhea during the study period, and at the follow-up 21 days | 
| Frequencies of other gastrointestinal symptoms | Frequencies of other gastrointestinal symptoms at 1, 2 and 4 weeks, in the L. reuteri group versus placebo and assessed by the validated GSRS score (Gastrointestinal Symptom Rating Score). | 1, 2 and 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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induced diarrhea, Clostridium difficile toxicity