Clinical trial NCT00641199: Probiotics for Prevention of Antibiotic-associated Diarrhea
Official title: The Effect of Jarro-Dophilus EPS Probiotics on the Prevention of Diarrhea, Quality of Life and Symptoms in Adults Receiving Antibiotic Therapy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Antibiotic-Associated Diarrhea
Keywords: Antibiotic-associated diarrhea
Probiotic
Quality of life
Antibiotics
Lead sponsor: University of Saskatchewan
Sponsor class: OTHER
Collaborators: name: Jarrow Formulas Inc
name: Institut Rosell
First posted: 2008-03-24
Enrollment: 204
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of patients experiencing diarrhea
timeFrame: Duration of antibiotic course plus 3 weeks
Secondary outcomes:
measure: Duration of diarrhea
timeFrame: Duration of antibiotic course plus 3 weeks
measure: Quality of life.
timeFrame: Duration of antibiotic course plus 3 weeks
measure: Gastrointestinal Symptom Rating Scale score.
timeFrame: Duration of antibiotic course plus 3 weeks
measure: Incidence of adverse effects.
timeFrame: Duration of antibiotic course plus 3 weeks
measure: Presence of pathogens in fecal samples.
timeFrame: Duration of antibiotic course
Other outcomes:
Locations:
city: Saskatoon
country: Canada
facility: University of Saskatchewan
state: Saskatchewan
Study officials:
affiliation: College of Pharmacy and Nutrition, University of Saskatchewan
name: Yvonne M Shevchuk, B.S.P., Pharm D.
role: PRINCIPAL_INVESTIGATOR
References: