Clinical trial NCT02076438: Probiotics for Prevention of Antibiotic Associated Diarrhea and Clostridium Difficile Associated Disease
Official title: Probiotics for Prevention of Antibiotic Associated Diarrhea and Clostridium Difficile Associated Disease in Hospitalized Adults-A Double Blind Placebo Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Diarrhea
Keywords: antibiotics
diarrhea
c diff
Hospitalized patients
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: Saint Peters University Hospital
First posted: 2014-03-03
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Diarrhea
timeFrame: 4 weeks
Secondary outcomes:
measure: Tolerability of probiotics
timeFrame: 4 weeks
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: Saint Peters University Hospital
state: New Jersey
Study officials:
affiliation: Rutgers University and Saint Peters University Hospital
name: Amita Avadhani, DNP
role: PRINCIPAL_INVESTIGATOR
References: