Trial record 3 of 127 for:    Open Studies | "Diarrhea"

Probiotics in Hospitalized Patients Study

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified December 2012 by South Shore Hospital
Sponsor:
Information provided by (Responsible Party):
South Shore Hospital
ClinicalTrials.gov Identifier:
NCT01596153
First received: May 8, 2012
Last updated: December 11, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention
Antibiotic Associated Diarrhea
Clostridium Difficile Associated Diarrhea
Dietary Supplement: Go Live

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

Resource links provided by NLM:


Further study details as provided by South Shore Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of Antibiotic associated diarrhea in patients randomized to Go Live Rx compared with those randomized to placebo [ Time Frame: 60 Days after hospitalization ] [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: February 2013
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
BID
Dietary Supplement: Go Live
Enhanced Probiotic, one packet bid until 7 days after discontinuation of antibiotic
Active Comparator: Go Live Rx Probiotic
BID
Dietary Supplement: Go Live
Enhanced Probiotic, one packet bid until 7 days after discontinuation of antibiotic

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01596153

Contacts
Contact: Todd B. Ellerin, MD 781-624-3617 todd_ellerin_md@sshosp.org
Contact: Simone S. Wildes, MD 781-624-3617 simone_wildes_md@sshosp.org

Locations
United States, Massachusetts
South Shore Hospital Not yet recruiting
Weymouth, Massachusetts, United States, 02190
Contact: Maureen Demenna, RN    781-624-8488    maureen_demenna@sshosp.org   
Principal Investigator: Todd B. Ellerin, MD         
Sponsors and Collaborators
South Shore Hospital
  More Information

No publications provided

Responsible Party: South Shore Hospital
ClinicalTrials.gov Identifier: NCT01596153     History of Changes
Other Study ID Numbers: SSH 10-006
Study First Received: May 8, 2012
Last Updated: December 11, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents

ClinicalTrials.gov processed this record on August 21, 2014