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Probiotics for Prevention of Antibiotic Associated Diarrhea and Clostridium Difficile Associated Disease

NCT ID: NCT02076438

Last Updated: 2016-11-23

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

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2016-09-30

Brief Summary

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The study will evaluate if administration of probiotic Culturelle (Lactobacillus Rhamnosus GG) along with antibiotics can help decrease the occurrence of diarrhea caused by antibiotics as well as Clostridium difficile Diarrhea.

Detailed Description

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Inpatient adult males and females who are at least 18 years of age or older, undergoing treatment with antibiotics irrespective of indication and the type of antibiotics. The setting is an academic hospital.The patients are screened and potentially recruited upon initiation of antibiotic treatment regardless of indication for antibiotic prescription. The participants are patients being admitted to any inpatient units of the hospital for treatment with antibiotics. Exclusion criteria is:

* Diarrhea on admission or within the preceding week
* Reported recurrent diarrhea
* Bowel pathology that could result in diarrhea (including preexisting Inflammatory Bowel disease{IBD}, all forms for colitis or any other condition resulting in preexisting diarrhea)
* Intake of high risk antibiotics (clindamycin, cephalosporins, aminopenicillins→ well known to cause CDAD) and or more than two courses of other antibiotics in the past four weeks to exclude pre-existing diarrhea associated with antibiotic use
* Immunosuppression (Chronic steroid use, Active chemotherapy, Active radiotherapy, HIV or any other disorder resulting in a compromise in participants immune status)
* Bowel surgery causing liquid stools
* Regular probiotic intake before admission
* Lactose intolerance or intolerance to dairy products.

Conditions

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Diarrhea

Keywords

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antibiotics diarrhea c diff Hospitalized patients

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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Placebo

Placebo capsules

Group Type PLACEBO_COMPARATOR

Probiotics

Intervention Type DIETARY_SUPPLEMENT

Randomized to receive probiotics or placebo

Probiotics

Lactobacillus Rhamnosus GG 10 billion cfu BID

Group Type EXPERIMENTAL

Probiotics

Intervention Type DIETARY_SUPPLEMENT

Randomized to receive probiotics or placebo

Interventions

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Probiotics

Randomized to receive probiotics or placebo

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Lactobacillus Rhamnosus GG 10 billion cfu bid

Eligibility Criteria

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Inclusion Criteria

* Inpatient adult males and females who are at least 18-89 years of age, undergoing treatment with antibiotics irrespective of indication and the type of antibiotics.

Exclusion Criteria

* Diarrhea on admission or within the preceding week
* Reported recurrent diarrhea
* Bowel pathology that could result in diarrhea (including preexisting Inflammatory Bowel disease{IBD}, all forms for colitis or any other condition resulting in preexisting diarrhea)
* Intake of high risk antibiotics (clindamycin, cephalosporins, aminopenicillins→ well known to cause CDAD) and or more than two courses of other antibiotics in the past four weeks to exclude pre-existing diarrhea associated with antibiotic use
* Immunosuppression (Chronic steroid use, Active chemotherapy, Active radiotherapy, HIV or any other disorder resulting in a compromise in participants immune status)
* Bowel surgery causing liquid stools
* Regular probiotic intake before admission
* Lactose intolerance or intolerance to dairy products
Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Saint Peters University Hospital

OTHER

Sponsor Role collaborator

Rutgers, The State University of New Jersey

OTHER

Sponsor Role lead

Responsible Party

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Amita Avadhani, DNP, DCC, ACNP, ANP, CCRN

Assistant Professor/Director Post MSN-DNP program

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Amita Avadhani, DNP

Role: PRINCIPAL_INVESTIGATOR

Rutgers University and Saint Peters University Hospital

Locations

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Saint Peters University Hospital

New Brunswick, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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Grant# PC 14-13

Identifier Type: OTHER

Identifier Source: secondary_id

Pro2012002450

Identifier Type: -

Identifier Source: org_study_id