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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

March 18, 2008
January 14, 2010
March 2008
September 2009   (final data collection date for primary outcome measure)
Incidence of patients experiencing diarrhea [ Time Frame: Duration of antibiotic course plus 3 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00641199 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Antibiotic-Associated Diarrhea
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
    Intervention: Other: Jarro-Dophilus EPS probiotics
  • Placebo Comparator: 2
    Placebo
    Intervention: Other: Jarro-Dophilus EPS probiotics
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
204
September 2009
September 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00641199
PAAD-07-112, 07-112
No
Yvonne M. Shevchuk, B.S.P., Pharm D, College of Pharmacy and Nutrition, University of Saskatchewan
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
University of Saskatchewan
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP