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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2014-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Development of Clostridium Difficile Associated Diarrhea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Theralac probiotic

Group Type ACTIVE_COMPARATOR

Theralac probiotic

Intervention Type DIETARY_SUPPLEMENT

Culturelle probiotic

Group Type ACTIVE_COMPARATOR

Culturelle probiotic

Intervention Type DIETARY_SUPPLEMENT

Placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

Interventions

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Theralac probiotic

Intervention Type DIETARY_SUPPLEMENT

Culturelle probiotic

Intervention Type DIETARY_SUPPLEMENT

placebo

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

\-

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

\-

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes