Bacillus Particles Prevent Children Antibiotics Associated Diarrhea

• ClinicalTrials.gov Identifier: NCT02993419
• Recruitment Status: Unknown
• First Posted: December 15, 2016
• Last Update Posted: December 15, 2016
• Sponsor: Jiangsu Famous Medical Technology Co., Ltd.
• Information provided by (Responsible Party): Jiangsu Famous Medical Technology Co., Ltd.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Antibiotic-associated Diarrhea	Drug: Bacillus licheniformis Intervention; Other: placebo Intervention	Phase 4

Detailed Description:

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

1. MAIN OUTCOME MEASURES: The incidence of diarrhea (stool frequency and character daily rates), the duration of diarrhea, the degree of diarrhea occur.
2. Secondary outcomes: intestinal flora and relevant metabolites, micro-environmental changes.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 480 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Bacillus Particles Prevent More Children's Antibiotic-associated Diarrhea (AAD), Randomized, Double-blind, Controlled Clinical Trial
• Study Start Date: December 2016
• Estimated Primary Completion Date: September 2017
• Estimated Study Completion Date: February 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: Bacillus licheniformis Intervention; 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; 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
Placebo Comparator: placebo Intervention; 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; 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

Outcome Measures

Primary Outcome Measures :

1. Record daily stool frequency, shape observation excrement [ Time Frame: every day，A total of seven days ]
   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

Secondary Outcome Measures :

1. Strain type [ Time Frame: the first day and the seven day ]
   Detection of intestinal strains of the species

Eligibility Criteria

• Ages Eligible for Study: 1 Month to 3 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

No Contacts or Locations Provided

More Information

• Responsible Party: Jiangsu Famous Medical Technology Co., Ltd.
• ClinicalTrials.gov Identifier: NCT02993419
• Other Study ID Numbers: dbzy160801
• First Posted: December 15, 2016
• Last Update Posted: December 15, 2016
• Last Verified: December 2016

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

Additional relevant MeSH terms:

Diarrhea; Signs and Symptoms, Digestive