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Antibiotic Associated Diarrhea | Probiotics in Hospitalized Patients Study

Antibiotic Associated Diarrhea research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Antibiotic Associated Diarrhea

Clostridium Difficile Associated Diarrhea

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Dietary Supplement:Go LiveEnhanced Probiotic, one packet bid until 7 days after discontinuation of antibiotic

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

PlaceboBID

Go Live Rx ProbioticBID

Study Status

Withdrawn

Start Date:

Completed Date:

Phase: N/A

Type: Interventional

Design:

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

Secondary Outcome: Incidence of Antibiotic associated diarrhea in patients randomized to Go Live Rx compared with those randomized to placebo

Study sponsors, principal investigator, and references

Principal Investigator:

Lead Sponsor: South Shore Hospital

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01596153

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