Probiotics for Prevention of Antibiotic-associated Diarrhea
Primary Purpose
Antibiotic-Associated Diarrhea
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Jarro-Dophilus EPS probiotics
Sponsored by
About this trial
This is an interventional prevention trial for Antibiotic-Associated Diarrhea focused on measuring Antibiotic-associated diarrhea, Probiotic, Quality of life, Antibiotics
Eligibility 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.
Sites / Locations
- University of Saskatchewan
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
1
2
Arm Description
Jarrow-Dophilus EPS
Placebo
Outcomes
Primary Outcome Measures
Incidence of patients experiencing diarrhea
Secondary Outcome Measures
Duration of diarrhea
Quality of life.
Gastrointestinal Symptom Rating Scale score.
Incidence of adverse effects.
Presence of pathogens in fecal samples.
Full Information
NCT ID
NCT00641199
First Posted
March 18, 2008
Last Updated
January 14, 2010
Sponsor
University of Saskatchewan
Collaborators
Jarrow Formulas Inc, Institut Rosell
1. Study Identification
Unique Protocol Identification Number
NCT00641199
Brief Title
Probiotics for Prevention of Antibiotic-associated Diarrhea
Official Title
The Effect of Jarro-Dophilus EPS Probiotics on the Prevention of Diarrhea, Quality of Life and Symptoms in Adults Receiving Antibiotic Therapy.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Saskatchewan
Collaborators
Jarrow Formulas Inc, Institut Rosell
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Antibiotic-Associated Diarrhea
Keywords
Antibiotic-associated diarrhea, Probiotic, Quality of life, Antibiotics
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
204 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Jarrow-Dophilus EPS
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Other
Intervention Name(s)
Jarro-Dophilus EPS probiotics
Intervention Description
Jarro-Dophilus EPS product 2 capsules twice daily. 4.4 billion live bacteria per capsule.
Primary Outcome Measure Information:
Title
Incidence of patients experiencing diarrhea
Time Frame
Duration of antibiotic course plus 3 weeks
Secondary Outcome Measure Information:
Title
Duration of diarrhea
Time Frame
Duration of antibiotic course plus 3 weeks
Title
Quality of life.
Time Frame
Duration of antibiotic course plus 3 weeks
Title
Gastrointestinal Symptom Rating Scale score.
Time Frame
Duration of antibiotic course plus 3 weeks
Title
Incidence of adverse effects.
Time Frame
Duration of antibiotic course plus 3 weeks
Title
Presence of pathogens in fecal samples.
Time Frame
Duration of antibiotic course
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yvonne M Shevchuk, B.S.P., Pharm D.
Organizational Affiliation
College of Pharmacy and Nutrition, University of Saskatchewan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Saskatchewan
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 5C9
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Probiotics for Prevention of Antibiotic-associated Diarrhea
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