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

South Shore Hospital0 sitesMay 10, 2012

ConditionsAntibiotic Associated Diarrhea Clostridium Difficile Associated Diarrhea

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Antibiotic Associated Diarrhea
Sponsor: South Shore Hospital
Primary Endpoint: Incidence of Clostridium difficle associated diarrhea in patients randomized to Go Live Rx compared with those randomized to placebo
Status: Withdrawn
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

May 10, 2012

End Date

TBD

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

South Shore Hospital

Responsible Party

Sponsor

Eligibility Criteria

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

•History of chronic diarrhea illness (Irritable Bowel Disease (IBD), Irritable Bowel Syndrome (IBS), Celiac Disease, Chronic pancreatitis
•Diarrhea at screening
•Active Colitis of any etiology
•History of colectomy
•Regular consumption of probiotics within 72 hours
•Unable to provide written consent
•History of or active pancreatitis
•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)
•Hypersensitivity to any ingredient in probiotic product
•Severe Immunosuppression (ANC \<1000, AIDS/CD4 count \<200 cells, cancer on active chemothereapy, h/o of solid or bone marrow transplant)

Outcomes

Primary Outcomes

Incidence of Clostridium difficle associated diarrhea in patients randomized to Go Live Rx compared with those randomized to placebo

Time Frame: 60 days after hospitalization

Secondary Outcomes

Incidence of Antibiotic associated diarrhea in patients randomized to Go Live Rx compared with those randomized to placebo(60 Days after hospitalization)