Probiotics in Hospitalized Patients Study

NCT01596153 | Withdrawn

• 1 other identifier: SSH 10-006
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Antibiotic Associated Diarrhea; Clostridium Difficile Associated Diarrhea

Outcome Measures

Primary Outcomes (1)

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

  60 days after hospitalization

Secondary Outcomes (1)

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

  60 Days after hospitalization

Study Arms (2)

Placebo

PLACEBO COMPARATOR

BID

Dietary Supplement: Go Live

Go Live Rx Probiotic

ACTIVE COMPARATOR

BID

Dietary Supplement: Go Live

Interventions

Go Live DIETARY_SUPPLEMENT

Enhanced Probiotic, one packet bid until 7 days after discontinuation of antibiotic

Go Live Rx Probiotic; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• \. 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

Sponsors & Collaborators

• South Shore Hospital: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2012
• First Posted: May 10, 2012
• Last Updated: November 18, 2014

Record last verified: 2014-11