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

NCT ID: NCT01143623

Last Updated: 2011-09-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

510 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2011-07-31

Brief Summary

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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

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Conditions

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Antibiotic-associated Diarrhea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Probiotic

Group Type ACTIVE_COMPARATOR

Probiotic

Intervention Type DIETARY_SUPPLEMENT

L. acidophilus, L. paracasei, B. lactis; 2.5 billion cfu capsule once per day

Probiotic-2

Group Type ACTIVE_COMPARATOR

Probiotic

Intervention Type DIETARY_SUPPLEMENT

L. acidophilus, L. paracasei, B. lactis; 10 billion cfu capsule once per day

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo

Interventions

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Probiotic

L. acidophilus, L. paracasei, B. lactis; 2.5 billion cfu capsule once per day

Intervention Type DIETARY_SUPPLEMENT

Probiotic

L. acidophilus, L. paracasei, B. lactis; 10 billion cfu capsule once per day

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* current diarrhea
* life threatening illness
* habitual probiotic use
Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Changhai Hospital

OTHER

Sponsor Role lead

Responsible Party

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Cai DongLian

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Changhai Hospital

Shanghai, , China

Site Status

Countries

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China

Other Identifiers

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09-SBC-2-DAN-03

Identifier Type: -

Identifier Source: org_study_id

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