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Probiotics in the Reduction of Antibiotic Associated Diarrhea

NCT ID: NCT02589964

Last Updated: 2016-10-31

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

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2015-07-31

Brief Summary

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The study will evaluate the effectiveness of probiotic therapy in reducing the incidence of antibiotic associated diarrhea (AAD) and Clostridium difficile associated diarrhea (CDAD) in pneumonia patients.

Detailed Description

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The study will include patients admitted to Good Samariatan Hospital and placed on the pneumonia order set. After obtaining consent, subjects will be randomized to the proboiotic or placebo group. Subjects will be followed for 21 days after starting the study treatment to determine critical outcomes such as incidence of antibiotic-associated diarrhea and C-Diff. Other outcomes include length of stay, healthcare costs, and death.

Conditions

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Clostridium Difficile

Keywords

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probiotics antibiotic associated diarrhea clostridium difficile

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Probiotic

Treatment will be initiated within 48 hours of the first antibiotic and will be administered twice a day for 20 days. The treatment is Florajen-3. The ingredients in Florajen-3 are:

Lactobacillus acidophilus-over 7.5 billion Bifidobacterium lactis-over 6.0 billion Bifidobacterium longum-over 1.5 billion

Group Type ACTIVE_COMPARATOR

Florajen-3

Intervention Type DIETARY_SUPPLEMENT

The probiotic treatment is the experimental aspect of the study. Treatment will be initiated within 48 hours of the first antibiotic and will be administered twice a day for 20 days.

Placebo

Placebo will be initiated within 48 hours of the first antibiotic and will be administered twice a day for 20 days. The ingredients in the placebo are:

Rice maltodextrin

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

The placebo treatment is the experimental aspect of the study. Treatment will be initiated within 48 hours of the first antibiotic and will be administered twice a day for 20 days.

Interventions

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Florajen-3

The probiotic treatment is the experimental aspect of the study. Treatment will be initiated within 48 hours of the first antibiotic and will be administered twice a day for 20 days.

Intervention Type DIETARY_SUPPLEMENT

Placebo

The placebo treatment is the experimental aspect of the study. Treatment will be initiated within 48 hours of the first antibiotic and will be administered twice a day for 20 days.

Intervention Type OTHER

Other Intervention Names

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probiotic

Eligibility Criteria

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Inclusion Criteria

* Admitted to Good Samaritan Hospital
* Placed on pneumonia order set
* Age 18+

Exclusion Criteria

* Patient with inadequate coherency to understand consent
* Active Diarrhea at admission
* Non-controlled intestinal disease
* Documented positive C. difficile infection within the 3 months before enrollment
* Antibiotic use at hospital admission
* Immunosuppressive therapy
* Pregnancy
* Allergic to ingredients in Florajen-3
* Allergic to ingredients in placebo
* Immunocompromised state including:
* HIV with a low CD4 count
* Active malignancy receiving chemotherapy
* Medications including long-term steroids (\>2 weeks), and disease modifying biologic agents
* Acquired immune deficiency
* Unable to take oral medication
* Less than 4 doses of probiotic or placebo
* Taking probiotic in the past 30 days
Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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TriHealth Inc.

OTHER

Sponsor Role lead

Responsible Party

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Jenni Steinbrunner

Research Specialist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Amita Buddhdev, MD

Role: PRINCIPAL_INVESTIGATOR

TriHealth Inc.

Locations

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TriHealth

Cincinnati, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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13085

Identifier Type: -

Identifier Source: org_study_id