Clinical Trial: Probiotics for Prevention of Antibiotic Associated Diarrhea and Clostridium Difficile Associated Disease

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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

Brief 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 Summary:

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.

Sponsor: Rutgers, The State University of New Jersey

Current Primary Outcome: Diarrhea [ Time Frame: 4 weeks ]

Diarrhea associated with antibiotics


Original Primary Outcome: Same as current

Current Secondary Outcome: Tolerability of probiotics [ Time Frame: 4 weeks ]

Patient experience with use of probiotics


Original Secondary Outcome: Same as current

Information By: Rutgers, The State University of New Jersey

Dates:
Date Received: February 25, 2014
Date Started: November 2015
Date Completion:
Last Updated: November 22, 2016
Last Verified: November 2016