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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.
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.
Outcome measures
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bacillus licheniformis Intervention | Experimental | The intervention is use Bacillus licheniformis particles,The 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 |
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| placebo Intervention | Placebo Comparator | The intervention is use placebo,The 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bacillus licheniformis Intervention | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Record daily stool frequency, shape observation excrement | Record daily stool frequency, excrement shape. According to Bristol who Chart of shape evaluation standard of excrement and urine, feces traits can be divided into seven grades, as picture shown in feces traits scale, record with feces corresponding score, score 5 or more, it indicates that the waste is not normal, diarrhea symptoms | every day,A total of seven days |
| Measure | Description | Time Frame |
|---|---|---|
| Strain type | Detection of intestinal strains of the species | the first day and the seven day |
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Inclusion Criteria:
Exclusion Criteria:
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| placebo Intervention | Other | 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 |
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