Probiotics in Hospitalized Patients Study
This study is not yet open for participant recruitment.
Verified December 2012 by South Shore Hospital
Sponsor:
South Shore Hospital
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
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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
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 |
Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013