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

Naval Military Medical University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Antibiotic-associated Diarrhea

Treatments: Dietary Supplement: Probiotic; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01143623

09-SBC-2-DAN-03

Details and patient eligibility

About

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

Enrollment: 510 patients

Sex: All

Ages: 30 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• current diarrhea
• life threatening illness
• habitual probiotic use

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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510 participants in 3 patient groups, including a placebo group

Probiotic

Active Comparator group

Treatment:

Dietary Supplement: Probiotic

Dietary Supplement: Probiotic

Probiotic-2

Active Comparator group

Treatment:

Dietary Supplement: Probiotic

Dietary Supplement: Probiotic

Placebo

Placebo Comparator group

Treatment:

Other: Placebo