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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by St. Vincent's East, Birmingham, Alabama
Sponsor:
Collaborator:
Master Supplements, Inc
Information provided by (Responsible Party):
St. Vincent's East, Birmingham, Alabama
ClinicalTrials.gov Identifier:
NCT01873872
First received: June 5, 2013
Last updated: March 26, 2014
Last verified: June 2013
  Purpose

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.


Condition Intervention
Development of Clostridium Difficile Associated Diarrhea
Dietary Supplement: Theralac probiotic
Dietary Supplement: Culturelle probiotic
Other: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Evaluation of Probiotics and the Development of Clostridium Difficile Associated Diarrhea in Patients Receiving Antibiotics

Resource links provided by NLM:


Further study details as provided by St. Vincent's East, Birmingham, Alabama:

Primary Outcome Measures:
  • Development of Clostridium difficile associated diarrhea in patients receiving antibiotics [ Time Frame: Up to six months ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: July 2013
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Theralac probiotic Dietary Supplement: Theralac probiotic
Active Comparator: Culturelle probiotic Dietary Supplement: Culturelle probiotic
Placebo Comparator: Placebo Other: placebo

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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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

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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.

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  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: NCT01873872

Contacts
Contact: Mark Middlebrooks, MD 205-380-0848 markmiddlebrooks@bellsouth.net

Locations
United States, Alabama
St. Vincent's East Recruiting
Birmingham, Alabama, United States, 35235
Contact: Leanne Phillips, Pharm.D    205-838-3109    leanne.phillips@stvhs.com   
Contact: Mark Middlebrooks, MD    205-380-0848    markmiddlebrooks@bellsouth.net   
Principal Investigator: Mark Middlebrooks, MD         
Sub-Investigator: Leanne Phillips, Pharm.D         
Sub-Investigator: Walter Ross, MD         
Sub-Investigator: Lee Wimberly, MD         
Sub-Investigator: Linda Adams, RPh         
Sub-Investigator: Carrie Castleberry, RN         
Sponsors and Collaborators
St. Vincent's East, Birmingham, Alabama
Master Supplements, Inc
Investigators
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
  More Information

No publications provided

Responsible Party: St. Vincent's East, Birmingham, Alabama
ClinicalTrials.gov Identifier: NCT01873872     History of Changes
Other Study ID Numbers: PROBIOTIC
Study First Received: June 5, 2013
Last Updated: March 26, 2014
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 01, 2014