Probiotics in Hospitalized Patients Study
| Status: | Completed |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/7/2015 |
| Start Date: | February 2013 |
| End Date: | October 2014 |
| Contact: | Todd B. Ellerin, MD |
| Email: | todd_ellerin_md@sshosp.org |
| Phone: | 781-624-3617 |
Randomized Double-blind, Placebo-Controlled Trial Comparing the the Effect of Enhance Probiotic (EP, Go Live Rx,) Versus Placebo (Pl) on the Incidence of Clostridium Difficile Associated Diarrhea (CDAD) or Antibiotic-Associated Diarrhea (AAD)in Hospitalized Patients Initiated on Antibiotics
The purpose of this study is to compare the effect of enhanced probiotic (EP, Live Rx)
versus placebo (PL) on the incidence of Clostridium difficile associated diarrhea (CDAD) or
antibiotic associated diarrhea (AAD) in hospitalized patients initiated on antibiotics.
versus placebo (PL) on the incidence of Clostridium difficile associated diarrhea (CDAD) or
antibiotic associated diarrhea (AAD) in hospitalized patients initiated on antibiotics.
Inclusion Criteria:
- 18 years of age or older admitted to SSH and prescribed antibiotics for an expected
duration >3 days (may include patients on antibiotics prior to admission).
Exclusion Criteria:
- 1. History of chronic diarrhea illness (Irritable Bowel Disease (IBD), Irritable
Bowel Syndrome (IBS), Celiac Disease, Chronic pancreatitis 2. Diarrhea at screening
3. Active Colitis of any etiology 4. History of colectomy 5. Regular consumption of
probiotics within 72 hours 6. Unable to provide written consent 7. History of or
active pancreatitis 8. Severe Sepsis or Septic Shock (sepsis with end organ failure
e.g. renal failure, ARDS, MS changes and or meets criteria by n ational guideline,
and or requiring vasopressors) 9. Hypersensitivity to any ingredient in probiotic
product 10. Severe Immunosuppression (ANC <1000, AIDS/CD4 count <200 cells, cancer on
active chemothereapy, h/o of solid or bone marrow transplant) 12. Acute burn
injuries
We found this trial at
1
site
Click here to add this to my saved trials
