NCT02076438

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

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: Rutgers, The State University of New Jersey · Academic / Other
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• Diarrhea

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Probiotics	Randomized to receive probiotics or placebo

Timeline

• Start date: 2015-11-01
• Primary completion: 2016-07-01
• Completion: 2016-09-01
• First posted: 2014-03-03
• Last updated: 2016-11-23

Locations

1 site across 1 country: United States