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

March 26, 2014 updated by: St. Vincent's East, Birmingham, Alabama

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35235
        • Recruiting
        • St. Vincent's East
        • Contact:
        • Contact:
        • 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Other: placebo
ACTIVE_COMPARATOR: Theralac probiotic
Dietary supplement: Theralac probiotic
ACTIVE_COMPARATOR: Culturelle probiotic
Dietary supplement: Culturelle probiotic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Development of Clostridium difficile associated diarrhea in patients receiving antibiotics
Time Frame: Up to six months
Up to six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Vincent's East, Birmingham, Alabama

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (ANTICIPATED)

March 1, 2014

Study Completion (ANTICIPATED)

March 1, 2014

Study Registration Dates

First Submitted

June 5, 2013

First Submitted That Met QC Criteria

June 5, 2013

First Posted (ESTIMATE)

June 10, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

March 28, 2014

Last Update Submitted That Met QC Criteria

March 26, 2014

Last Verified

June 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PROBIOTIC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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