Diarrhea
Conditions
Keywords
antibiotics, diarrhea, c diff, Hospitalized patients
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.
Interventions
DIETARY_SUPPLEMENTProbiotics
Randomized to receive probiotics or placebo
Sponsors
Saint Peters University Hospital
Rutgers, The State University of New Jersey
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diarrhea | 4 weeks | Diarrhea associated with antibiotics |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tolerability of probiotics | 4 weeks | Patient experience with use of probiotics |
Countries
United States
Outcome results
None listed