Bacillus Particles Prevent Children Antibiotics Associated Diarrhea

NCT02993419 | Unknown Phase 4

• 1 other identifier: dbzy160801
• Study Type: interventional
• Target: 480
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Strain type

  the first day and the seven day

Study Arms (2)

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

Drug: Bacillus licheniformis Intervention

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

Other: placebo Intervention

Interventions

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

Bacillus licheniformis Intervention

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

placebo Intervention

Eligibility Criteria

• Age: 1 Month - 3 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 1-3 years
• no diarrhea-related symptoms
• the diagnosis of lower respiratory tract infection (acute bronchitis, pneumonia) in hospitalized children
• the need for penicillins, cephalosporin antibiotic treatment, treatment for 7-14 days, combined with other antimicrobial agents alone
• parent or guardian signed informed consent (6）Not used in children with related traditional Chinese medicine injection

You may not qualify if:

• diarrhea in the group, or 2 weeks before admission into children with diarrhea
• children with ICU wards, digestive tract malformations, children with gastrointestinal surgery, congenital heart disease, artificial heart surgery, children with rheumatic heart disease, infective endocarditis
• receiving immunosuppressive agents in children
• Children who received any probiotic preparation 2 weeks before enrollment

Sponsors & Collaborators

• Jiangsu Famous Medical Technology Co., Ltd.: lead

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2016
• First Posted: December 15, 2016
• Study Start: December 1, 2016
• Primary Completion: September 1, 2017
• Study Completion: February 1, 2018
• Last Updated: December 15, 2016

Record last verified: 2016-12