Probiotics in Hospitalized Patients Study

Antibiotic Associated Diarrhea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01596153
• Other study ID #: SSH 10-006
• Status: Withdrawn
• Phase: N/A
• First received: May 8, 2012
• Last updated: November 17, 2014

Study information

• Verified date: November 2014
• Source: South Shore Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Antibiotic Associated Diarrhea
• Clostridium Difficile Associated Diarrhea
• Diarrhea

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
South Shore Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Clostridium difficle associated diarrhea in patients randomized to Go Live Rx compared with those randomized to placebo		60 days after hospitalization	No
Secondary	Incidence of Antibiotic associated diarrhea in patients randomized to Go Live Rx compared with those randomized to placebo		60 Days after hospitalization	No