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

Primary Purpose

Development of Clostridium Difficile Associated Diarrhea

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Theralac probiotic

Culturelle probiotic

placebo

About this trial

This is an interventional prevention trial for Development of Clostridium Difficile Associated Diarrhea

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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Participants will be withdrawn from the study if they develop any of the exclusion criteria during the hospitalization.

Sites / Locations

St. Vincent's EastRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Theralac probiotic

Culturelle probiotic

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Development of Clostridium difficile associated diarrhea in patients receiving antibiotics

Secondary Outcome Measures

Full Information

NCT ID

NCT01873872

First Posted

June 5, 2013

Last Updated

March 26, 2014

Sponsor

St. Vincent's East, Birmingham, Alabama

Collaborators

Master Supplements, Inc

1. Study Identification

Unique Protocol Identification Number

NCT01873872

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2013

Overall Recruitment Status

Unknown status

Study Start Date

July 2013 (undefined)

Primary Completion Date

March 2014 (Anticipated)

Study Completion Date

March 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

St. Vincent's East, Birmingham, Alabama

Collaborators

Master Supplements, Inc

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Development of Clostridium Difficile Associated Diarrhea

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Theralac probiotic

Arm Type

Active Comparator

Arm Title

Culturelle probiotic

Arm Type

Active Comparator

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Dietary Supplement

Intervention Name(s)

Theralac probiotic

Intervention Type

Dietary Supplement

Intervention Name(s)

Culturelle probiotic

Intervention Type

Other

Intervention Name(s)

placebo

Primary Outcome Measure Information:

Title

Development of Clostridium difficile associated diarrhea in patients receiving antibiotics

Time Frame

Up to six months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility Criteria

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: Absolute neutrophil count (ANC) ≤ 500 cells/mm3 HIV Cancer patient receiving chemotherapy or radiation therapy Immune deficiency Post organ transplant Participants will be withdrawn from the study if they develop any of the exclusion criteria during the hospitalization. -

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mark Middlebrooks, MD

Phone

205-380-0848

markmiddlebrooks@bellsouth.net

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Leanne Phillips, Pharm.D

Organizational Affiliation

St. Vincent's East

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Walter Ross, MD

Organizational Affiliation

St. Vincent's East

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Mark Middlebrooks, MD

Organizational Affiliation

St. Vincent's East

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Lee Wimberly, MD

Organizational Affiliation

St. Vincent's East

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Linda Adams, RPh

Organizational Affiliation

St. Vincent's East

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Carrie Castleberry, RN

Organizational Affiliation

St. Vincent's East

Official's Role

Principal Investigator

Facility Information:

Facility Name

St. Vincent's East

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35235

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Leanne Phillips, Pharm.D

Phone

205-838-3109

leanne.phillips@stvhs.com

First Name & Middle Initial & Last Name & Degree

Mark Middlebrooks, MD

Phone

205-380-0848

markmiddlebrooks@bellsouth.net

First Name & Middle Initial & Last Name & Degree

Mark Middlebrooks, MD

First Name & Middle Initial & Last Name & Degree

Leanne Phillips, Pharm.D

First Name & Middle Initial & Last Name & Degree

Walter Ross, MD

First Name & Middle Initial & Last Name & Degree

Lee Wimberly, MD

First Name & Middle Initial & Last Name & Degree

Linda Adams, RPh

First Name & Middle Initial & Last Name & Degree

Carrie Castleberry, RN

12. IPD Sharing Statement

Learn more about this trial

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

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