Probiotics for Prevention of Antibiotic-associated Diarrhea

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

COMPLETED

Clinical Phase

NA

Total Enrollment

204 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2009-09-30

Brief Summary

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The purpose of this study is to evaluate if ingestion of a probiotic formula (Jarrow-Dophilus EPS)reduces incidence of diarrhea and improves the quality of life of patients receiving antibiotic therapy.

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Detailed Description

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A common complication of antibiotic use is antibiotic-induced diarrhea (AAD). AAD is the result of disrupted microflora, occurring two to eight weeks after antibiotic use. Probiotic supplementation may rebalance the intestinal flora, thus reducing the incidence of diarrhea, improving quality of life and reducing symptoms associated with antibiotic administration.

The proposed study will be a prospective, randomized, double blind, placebo-controlled trial that will assess the efficacy of the Jarro-Dophilus EPS probiotics formula for the prevention of AAD.

In addition,a subgroup of participants will be requested to provide one fecal sample at the initiation of the study and one sample in the last three days of probiotic (or placebo) treatment. The samples will undergo microbial analysis for routine C \& S(Salmonella, Shigella, Campylobacter, Ecoli 0157, Yersinia), VRE, Yeast, Fungus culture (moulds) and C. difficile toxin.

Conditions

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Antibiotic-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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1

Jarrow-Dophilus EPS

Group Type ACTIVE_COMPARATOR

Jarro-Dophilus EPS probiotics

Intervention Type OTHER

Jarro-Dophilus EPS product 2 capsules twice daily. 4.4 billion live bacteria per capsule.

2

Placebo

Group Type PLACEBO_COMPARATOR

Jarro-Dophilus EPS probiotics

Intervention Type OTHER

Jarro-Dophilus EPS product 2 capsules twice daily. 4.4 billion live bacteria per capsule.

Interventions

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Jarro-Dophilus EPS probiotics

Jarro-Dophilus EPS product 2 capsules twice daily. 4.4 billion live bacteria per capsule.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 18-75 years of age
* Prescribed oral or IV antibiotics by physicians in Saskatoon Health Region's community medical clinics

Exclusion Criteria

* Treatment with an antibiotic two weeks prior to study entry
* Underlying long term gastrointestinal disease (i.e., Ulcerative Colitis, Crohn's Disease, irritable bowel syndrome, ileostomy, colostomy)
* Pregnant or lactating
* Immunocompromised state
* Chronic illness such as Hepatitis B, Hepatitis C, renal failure
* Inability to provide informed consent, inability to speak or write in English
* Receiving tube feeds
* Insufficiently functional (physically and cognitively) to complete the study diary and questionnaires.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No