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Probiotics for Prevention of Antibiotic-associated Diarrhea

This study has been completed.
Jarrow Formulas Inc
Institut Rosell
Information provided by:
University of Saskatchewan Identifier:
First received: March 18, 2008
Last updated: January 14, 2010
Last verified: January 2010
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.

Condition Intervention
Antibiotic-Associated Diarrhea
Other: Jarro-Dophilus EPS probiotics

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effect of Jarro-Dophilus EPS Probiotics on the Prevention of Diarrhea, Quality of Life and Symptoms in Adults Receiving Antibiotic Therapy.

Resource links provided by NLM:

Further study details as provided by University of Saskatchewan:

Primary Outcome Measures:
  • Incidence of patients experiencing diarrhea [ Time Frame: Duration of antibiotic course plus 3 weeks ]

Secondary Outcome Measures:
  • Duration of diarrhea [ Time Frame: Duration of antibiotic course plus 3 weeks ]
  • Quality of life. [ Time Frame: Duration of antibiotic course plus 3 weeks ]
  • Gastrointestinal Symptom Rating Scale score. [ Time Frame: Duration of antibiotic course plus 3 weeks ]
  • Incidence of adverse effects. [ Time Frame: Duration of antibiotic course plus 3 weeks ]
  • Presence of pathogens in fecal samples. [ Time Frame: Duration of antibiotic course ]

Estimated Enrollment: 204
Study Start Date: March 2008
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Jarrow-Dophilus EPS
Other: Jarro-Dophilus EPS probiotics
Jarro-Dophilus EPS product 2 capsules twice daily. 4.4 billion live bacteria per capsule.
Placebo Comparator: 2
Other: Jarro-Dophilus EPS probiotics
Jarro-Dophilus EPS product 2 capsules twice daily. 4.4 billion live bacteria per capsule.

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.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00641199

Canada, Saskatchewan
University of Saskatchewan
Saskatoon, Saskatchewan, Canada, S7N 5C9
Sponsors and Collaborators
University of Saskatchewan
Jarrow Formulas Inc
Institut Rosell
Principal Investigator: Yvonne M Shevchuk, B.S.P., Pharm D. College of Pharmacy and Nutrition, University of Saskatchewan
  More Information

Responsible Party: Yvonne M. Shevchuk, B.S.P., Pharm D, College of Pharmacy and Nutrition, University of Saskatchewan Identifier: NCT00641199     History of Changes
Other Study ID Numbers: PAAD-07-112
Study First Received: March 18, 2008
Last Updated: January 14, 2010

Keywords provided by University of Saskatchewan:
Antibiotic-associated diarrhea
Quality of life

Additional relevant MeSH terms:
Signs and Symptoms, Digestive
Signs and Symptoms
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents processed this record on May 25, 2017