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NCT01143623 Clinical Trial

Dose Response Effect of Probiotics for the Prevention of Antibiotic-associated Diarrhea in Chinese Adults

Antibiotic-associated Diarrhea Clinical Trial

Official title:
Dose Response Effect of a Proprietary Probiotic Formula for the Prevention of Antibiotic-associated Diarrhea in Chinese Adults

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01143623
Other study ID # 09-SBC-2-DAN-03
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received June 11, 2010
Last updated September 19, 2011
Start date May 2010
Est. completion date July 2011

Study information
Verified date September 2011
Source Changhai Hospital
Contact n/a
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine the dose response effect of probiotic capsules for the prevention of antibiotic-associated diarrhea (AAD).

Recruitment information / eligibility
Status Completed
Enrollment 510
Est. completion date July 2011
Est. primary completion date July 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 30 Years to 70 Years
Eligibility Inclusion Criteria:

- age 30-70 years

- initiating antibiotic therapy

- informed consent

Exclusion Criteria:

- current diarrhea

- life threatening illness

- habitual probiotic use

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Probiotic
L. acidophilus, L. paracasei, B. lactis; 2.5 billion cfu capsule once per day
• Probiotic
L. acidophilus, L. paracasei, B. lactis; 10 billion cfu capsule once per day
Other:
• Placebo
Placebo

Locations
Country Name City State
China Changhai Hospital Shanghai

Sponsors (1)
Lead Sponsor Collaborator
Changhai Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of antibiotic-associated diarrhea 5 weeks after antibiotic discontinuation No
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