Probiotics for Prevention of Antibiotic-associated Diarrhea

University of Saskatchewan

Status: Completed

Conditions: Antibiotic-Associated Diarrhea

Treatments: Other: Jarro-Dophilus EPS probiotics

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00641199

07-112

PAAD-07-112

Details and patient eligibility

About

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.

Full 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.

Enrollment: 204 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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204 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

Jarrow-Dophilus EPS

Treatment:

Other: Jarro-Dophilus EPS probiotics

2

Placebo Comparator group

Description:

Placebo

Treatment:

Other: Jarro-Dophilus EPS probiotics