Clostridium Difficile
Conditions
Keywords
probiotics, antibiotic associated diarrhea, clostridium difficile
Brief summary
The study will evaluate the effectiveness of probiotic therapy in reducing the incidence of antibiotic associated diarrhea (AAD) and Clostridium difficile associated diarrhea (CDAD) in pneumonia patients.
Detailed description
The study will include patients admitted to Good Samariatan Hospital and placed on the pneumonia order set. After obtaining consent, subjects will be randomized to the proboiotic or placebo group. Subjects will be followed for 21 days after starting the study treatment to determine critical outcomes such as incidence of antibiotic-associated diarrhea and C-Diff. Other outcomes include length of stay, healthcare costs, and death.
Interventions
DIETARY_SUPPLEMENTFlorajen-3
The probiotic treatment is the experimental aspect of the study. Treatment will be initiated within 48 hours of the first antibiotic and will be administered twice a day for 20 days.
OTHERPlacebo
The placebo treatment is the experimental aspect of the study. Treatment will be initiated within 48 hours of the first antibiotic and will be administered twice a day for 20 days.
Sponsors
TriHealth Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
Inclusion criteria
* Admitted to Good Samaritan Hospital * Placed on pneumonia order set * Age 18+
Exclusion criteria
* Patient with inadequate coherency to understand consent * Active Diarrhea at admission * Non-controlled intestinal disease * Documented positive C. difficile infection within the 3 months before enrollment * Antibiotic use at hospital admission * Immunosuppressive therapy * Pregnancy * Allergic to ingredients in Florajen-3 * Allergic to ingredients in placebo * Immunocompromised state including: * HIV with a low CD4 count * Active malignancy receiving chemotherapy * Medications including long-term steroids (\>2 weeks), and disease modifying biologic agents * Acquired immune deficiency * Unable to take oral medication * Less than 4 doses of probiotic or placebo * Taking probiotic in the past 30 days
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Antibiotic Associated Diarrhea | 21 days after starting study treatment | Subjects will be asked to keep a diary for 20 days after starting study treatment and will be contacted by a nurse approximately 21 days after starting study treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of stay | during hospitalization up to 4 weeks | — |
| Mortality | During hospitalization up to 4 weeks | — |
| Healthcare costs | During hospitalization up to 4 weeks | Healthcare costs include direct costs during hospital stay (room, meds, procedures). This is obtained through the TriHealth Decision Support department. |
| Clostridium difficile | 21 days after initiating study treatment | Data is obtained though a follow-up call to the patient. |
Countries
United States
Outcome results
None listed