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.

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.

Study Overview

• Status: Completed
• Conditions: Antibiotic-Associated Diarrhea
• Intervention / Treatment: Other: Jarro-Dophilus EPS probiotics

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 Type: Interventional
• Enrollment (Anticipated): 204
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7N 5C9
      • University of Saskatchewan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 2; Placebo	Other: Jarro-Dophilus EPS probiotics; Jarro-Dophilus EPS product 2 capsules twice daily. 4.4 billion live bacteria per capsule.
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: University of Saskatchewan
• Collaborators: Jarrow Formulas Inc; Institut Rosell
• Investigators: Principal Investigator: Yvonne M Shevchuk, B.S.P., Pharm D., College of Pharmacy and Nutrition, University of Saskatchewan

Study record dates

Study Major Dates

• Study Start: March 1, 2008
• Primary Completion (Actual): September 1, 2009
• Study Completion (Actual): September 1, 2009

Study Registration Dates

• First Submitted: March 18, 2008
• First Submitted That Met QC Criteria: March 21, 2008
• First Posted (Estimate): March 24, 2008

Study Record Updates

• Last Update Posted (Estimate): January 15, 2010
• Last Update Submitted That Met QC Criteria: January 14, 2010
• Last Verified: January 1, 2010

More Information

Terms related to this study

• Keywords: Quality of life; Antibiotics; Probiotic; Antibiotic-associated diarrhea
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Diarrhea
• Other Study ID Numbers: PAAD-07-112; 07-112