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



Status:Terminated
Conditions:Irritable Bowel Syndrome (IBS), Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 89
Updated:11/24/2016
Start Date:November 2015
End Date:September 2016

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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

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.

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.

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
We found this trial at
1
site
254 Easton Ave
New Brunswick, New Jersey 08901
(732) 745-8600
Phone: 732-745-8600
Saint Peter's University Hospital Located in New Brunswick, NJ, Saint Peter's University Hospital has been...
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mi
from
New Brunswick, NJ
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