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Evaluation of Probiotics and the Development of Clostridium Difficile Associated Diarrhea in Patients Receiving Antibiotics

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ClinicalTrials.gov Identifier: NCT01873872
Recruitment Status : Unknown
Verified June 2013 by St. Vincent's East, Birmingham, Alabama.
Recruitment status was:  Recruiting
First Posted : June 10, 2013
Last Update Posted : March 28, 2014
Sponsor:
Collaborator:
Master Supplements, Inc
Information provided by (Responsible Party):
St. Vincent's East, Birmingham, Alabama

Tracking Information
First Submitted Date  ICMJE June 5, 2013
First Posted Date  ICMJE June 10, 2013
Last Update Posted Date March 28, 2014
Study Start Date  ICMJE July 2013
Estimated Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 5, 2013)
Development of Clostridium difficile associated diarrhea in patients receiving antibiotics [ Time Frame: Up to six months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01873872 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Probiotics and the Development of Clostridium Difficile Associated Diarrhea in Patients Receiving Antibiotics
Official Title  ICMJE Evaluation of Probiotics and the Development of Clostridium Difficile Associated Diarrhea in Patients Receiving Antibiotics
Brief Summary

We have designed this study to measure the effect of normal flora supplementation, using available probiotics, on the incidence of Clostridium difficile-associated diarrhea

in a population of general inpatients who are receiving antibiotics.

Detailed Description General medical-surgical patients in a community hospital who are receiving antibiotics, and who agree to participate, will be given one of two different probiotics, or placebo. Data will be gathered during their hospitalization, and at one and three months following hospital discharge. We expect to see a lower incidence of Clostridium difficile-associated diarrhea in the probiotic groups when compared to the placebo group. We will also be looking for differences between the effects of the two probiotics, which differ in strain types and number of colony forming units per dose.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Development of Clostridium Difficile Associated Diarrhea
Intervention  ICMJE
  • Dietary Supplement: Theralac probiotic
  • Dietary Supplement: Culturelle probiotic
  • Other: placebo
Study Arms  ICMJE
  • Active Comparator: Theralac probiotic
    Intervention: Dietary Supplement: Theralac probiotic
  • Active Comparator: Culturelle probiotic
    Intervention: Dietary Supplement: Culturelle probiotic
  • Placebo Comparator: Placebo
    Intervention: Other: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 5, 2013)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2014
Estimated Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria: Any hospitalized patient who is age 19 or older and receiving antibiotics.

-

Exclusion Criteria:

  • Feeding tube in place
  • Pregnancy
  • Milk or soy allergy
  • Sensitivity to lactose
  • Immunocompromised defined as:

    1. Absolute neutrophil count (ANC) ≤ 500 cells/mm3
    2. HIV
    3. Cancer patient receiving chemotherapy or radiation therapy
    4. Immune deficiency
    5. Post organ transplant

Participants will be withdrawn from the study if they develop any of the exclusion criteria during the hospitalization.

-

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01873872
Other Study ID Numbers  ICMJE PROBIOTIC
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party St. Vincent's East, Birmingham, Alabama
Study Sponsor  ICMJE St. Vincent's East, Birmingham, Alabama
Collaborators  ICMJE Master Supplements, Inc
Investigators  ICMJE
Principal Investigator: Leanne Phillips, Pharm.D St. Vincent's East
Principal Investigator: Walter Ross, MD St. Vincent's East
Principal Investigator: Mark Middlebrooks, MD St. Vincent's East
Principal Investigator: Lee Wimberly, MD St. Vincent's East
Principal Investigator: Linda Adams, RPh St. Vincent's East
Principal Investigator: Carrie Castleberry, RN St. Vincent's East
PRS Account St. Vincent's East, Birmingham, Alabama
Verification Date June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP