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

Phase 2

Completed

• Conditions: Antibiotic-associated Diarrhea
• Interventions: Dietary Supplement: Probiotic; Other: Placebo

• Registration Number: NCT01143623
• Lead Sponsor: Changhai Hospital

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-06-11
• Study First Submitted QC: 2010-06-11
• Study First Posted: 2010-06-14
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Status Verified: 2011-09
• Last Update Submitted: 2011-09-19
• Last Update Posted: 2011-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 510

Inclusion Criteria

• age 30-70 years
• initiating antibiotic therapy
• informed consent

Exclusion Criteria

• current diarrhea
• life threatening illness
• habitual probiotic use

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotic-2	Probiotic	-
Placebo	Placebo	-
Probiotic	Probiotic	-

Primary Outcome Measures

Name	Time	Method
Incidence of antibiotic-associated diarrhea	5 weeks after antibiotic discontinuation

Trial Locations

Locations (1)

Changhai Hospital; 🇨🇳 Shanghai, China