Probiotics for Prevention of Antibiotic-associated Diarrhea

This study has been completed.
Sponsor:
Collaborators:
Jarrow Formulas Inc
Institut Rosell
Information provided by:
University of Saskatchewan
ClinicalTrials.gov Identifier:
NCT00641199
First received: March 18, 2008
Last updated: January 14, 2010
Last verified: January 2010
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Duration of diarrhea [ Time Frame: Duration of antibiotic course plus 3 weeks ] [ Designated as safety issue: No ]
  • Quality of life. [ Time Frame: Duration of antibiotic course plus 3 weeks ] [ Designated as safety issue: No ]
  • Gastrointestinal Symptom Rating Scale score. [ Time Frame: Duration of antibiotic course plus 3 weeks ] [ Designated as safety issue: No ]
  • Incidence of adverse effects. [ Time Frame: Duration of antibiotic course plus 3 weeks ] [ Designated as safety issue: Yes ]
  • Presence of pathogens in fecal samples. [ Time Frame: Duration of antibiotic course ] [ Designated as safety issue: No ]

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
Placebo
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00641199

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

No publications provided

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

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

Additional relevant MeSH terms:
Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents

ClinicalTrials.gov processed this record on April 21, 2014