Back to resultsDose Response Effect of Probiotics for the Prevention of Antibiotic-associated Diarrhea in Chinese Adults
Primary Purpose
Antibiotic-associated Diarrhea
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Probiotic
Probiotic
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Antibiotic-associated Diarrhea focused on measuring antibiotic, diarrhea, probiotic
Eligibility Criteria
Inclusion Criteria:
- age 30-70 years
- initiating antibiotic therapy
- informed consent
Exclusion Criteria:
- current diarrhea
- life threatening illness
- habitual probiotic use
Sites / Locations
- Changhai Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
Probiotic
Probiotic-2
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Incidence of antibiotic-associated diarrhea
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01143623
Brief Title
Dose Response Effect of Probiotics for the Prevention of Antibiotic-associated Diarrhea in Chinese Adults
Official Title
Dose Response Effect of a Proprietary Probiotic Formula for the Prevention of Antibiotic-associated Diarrhea in Chinese Adults
Study Type
Interventional
2. Study Status
Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Changhai Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine the dose response effect of probiotic capsules for the prevention of antibiotic-associated diarrhea (AAD).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Antibiotic-associated Diarrhea
Keywords
antibiotic, diarrhea, probiotic
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
510 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Probiotic
Arm Type
Active Comparator
Arm Title
Probiotic-2
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotic
Intervention Description
L. acidophilus, L. paracasei, B. lactis; 2.5 billion cfu capsule once per day
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotic
Intervention Description
L. acidophilus, L. paracasei, B. lactis; 10 billion cfu capsule once per day
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Incidence of antibiotic-associated diarrhea
Time Frame
5 weeks after antibiotic discontinuation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
age 30-70 years
initiating antibiotic therapy
informed consent
Exclusion Criteria:
current diarrhea
life threatening illness
habitual probiotic use
Facility Information:
Facility Name
Changhai Hospital
City
Shanghai
Country
China
12. IPD Sharing Statement
Learn more about this trial
Dose Response Effect of Probiotics for the Prevention of Antibiotic-associated Diarrhea in Chinese Adults
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