Probiotics for Prevention of Antibiotic-associated Diarrhea

Not Applicable

Completed

• Conditions: Antibiotic-Associated Diarrhea
• Interventions: Other: Jarro-Dophilus EPS probiotics

• Registration Number: NCT00641199
• Lead Sponsor: University of Saskatchewan

Brief Summary

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

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.

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-03-18
• Study First Submitted QC: 2008-03-21
• Study First Posted: 2008-03-24
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Status Verified: 2010-01
• Last Update Submitted: 2010-01-14
• Last Update Posted: 2010-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 204

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Jarro-Dophilus EPS probiotics	Jarrow-Dophilus EPS
2	Jarro-Dophilus EPS probiotics	Placebo

Primary Outcome Measures

Name	Time	Method
Incidence of patients experiencing diarrhea	Duration of antibiotic course plus 3 weeks

Secondary Outcome Measures

Name	Time	Method
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
Presence of pathogens in fecal samples.	Duration of antibiotic course
Incidence of adverse effects.	Duration of antibiotic course plus 3 weeks

Trial Locations

Locations (1)

University of Saskatchewan; 🇨🇦 Saskatoon, Saskatchewan, Canada