Probiotics for Prevention of Antibiotic-associated Diarrhea

Study Overview
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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.

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.

Official Title
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The Effect of Jarro-Dophilus EPS Probiotics on the Prevention of Diarrhea, Quality of Life and Symptoms in Adults Receiving Antibiotic Therapy.

Conditions
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Antibiotic-Associated Diarrhea

Intervention / Treatment
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* Other: Jarro-Dophilus EPS probiotics


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Jarrow-Dophilus EPS | Other: Jarro-Dophilus EPS probiotics<br>* Jarro-Dophilus EPS product 2 capsules twice daily. 4.4 billion live bacteria per capsule.<br>|
| Placebo Comparator: 2<br>Placebo | Other: Jarro-Dophilus EPS probiotics<br>* Jarro-Dophilus EPS product 2 capsules twice daily. 4.4 billion live bacteria per capsule.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of patients experiencing diarrhea |  | Duration of antibiotic course plus 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of diarrhea |  | Duration of antibiotic course plus 3 weeks | 
| Quality of life. |  | Duration of antibiotic course plus 3 weeks | 
| Gastrointestinal Symptom Rating Scale score. |  | Duration of antibiotic course plus 3 weeks | 
| Incidence of adverse effects. |  | Duration of antibiotic course plus 3 weeks | 
| Presence of pathogens in fecal samples. |  | Duration of antibiotic course | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Antibiotic-associated diarrhea, Probiotic, Quality of life, Antibiotics