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Probiotics in Hospitalized Patients Study

NCT ID: NCT01596153

Last Updated: 2014-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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Conditions

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Antibiotic Associated Diarrhea Clostridium Difficile Associated Diarrhea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

BID

Group Type PLACEBO_COMPARATOR

Go Live

Intervention Type DIETARY_SUPPLEMENT

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

Go Live Rx Probiotic

BID

Group Type ACTIVE_COMPARATOR

Go Live

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Go Live

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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South Shore Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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SSH 10-006

Identifier Type: -

Identifier Source: org_study_id