Probiotics for Prevention of Antibiotic-associated Diarrhea

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00641199

Enrollment

204

Registered

2008-03-24

Start date

2008-03-31

Completion date

2009-09-30

Last updated

2010-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antibiotic-Associated Diarrhea

Keywords

Antibiotic-associated diarrhea, Probiotic, Quality of life, Antibiotics

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.

Interventions

OTHERJarro-Dophilus EPS probiotics

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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.

Design outcomes

Primary

Measure	Time frame
Incidence of patients experiencing diarrhea	Duration of antibiotic course plus 3 weeks

Secondary

Measure	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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026