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Bacillus Particles Prevent Children Antibiotics Associated Diarrhea

NCT02993419 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 480

Last updated 2016-12-15

No results posted yet for this study

Summary

This prospective, multicenter, randomized, double-blind, placebo-controlled clinical study, into the group of children in the hospital that use clinical antibiotics from one month to three years old，by observing the given antibiotics at the same time with the whole bowel raw or placebo, prevent the happening of the antibiotic associated diarrhea, evaluate the whole bowel prevention clinical efficacy and safety of AAD.

Conditions

  • Antibiotic-associated Diarrhea

Interventions

DRUG

Bacillus licheniformis Intervention

On the basis of the use of antibiotics in children with symptomatic treatment, the addition of experimental drugs 1 bag each time, three times a day, for taking seven days; children observed during the test is no longer taking other probiotic preparations, and any other proprietary Chinese medicine preparation

OTHER

placebo Intervention

On the basis of the use of antibiotics in children with symptomatic treatment, the addition of placebo drugs 1 bag each time, three times a day, for taking seven days; children observed during the test is no longer taking other probiotic preparations, and any other proprietary Chinese medicine preparation

Sponsors & Collaborators

  • Jiangsu Famous Medical Technology Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Month
Max Age
3 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-31
Primary Completion
2017-09-30
Completion
2018-02-28

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02993419 on ClinicalTrials.gov