Antibiotic-associated DiarrheaPhase 4NCT02993419
Bacillus Particles Prevent Children Antibiotics Associated Diarrhea
A Phase 4 study testing Bacillus licheniformis Intervention in people with Antibiotic-associated Diarrhea, run by Jiangsu Famous Medical Technology Co., Ltd..
Trial 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… Read more about this study
- Who is it for?
- Ages 1 month to 3 years
- Conditions the study is for
- Antibiotic-associated Diarrhea
- What is being tested?
- Bacillus licheniformis Intervention
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 480 participants
- Where
- No sites listed yet
- Study dates
- Dec 2016to Feb 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 3 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Bacillus Particles Prevent More Children's Antibiotic-associated Diarrhea (AAD), Randomized, Double-blind, Controlled Clinical Trial
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.
Read the 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
- MAIN OUTCOME MEASURES: The incidence of diarrhea (stool frequency and character daily rates), the duration of diarrhea, the degree of diarrhea occur.
- Secondary outcomes: intestinal flora and relevant metabolites, micro-environmental changes.
- Conditions
- Antibiotic-associated Diarrhea
- Being tested
- Bacillus licheniformis Intervention, placebo Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bacillus licheniformis InterventionDrug
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 InterventionOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: placebo Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: every day，A total of seven days
Secondary outcomes (1)
Strain type
Detection of intestinal strains of the species
Measured: the first day and the seven day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionSep 2017 (estimated)
- Study completionFeb 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antibiotic-associated DiarrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Famous Medical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02993419
- Sponsor's protocol ID
- dbzy160801
- Status last verified
- Dec 2016
- First submitted
- 18 Aug 2016
- Last updated
- 15 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bacillus Particles Prevent More Children's Antibiotic-associated Diarrhea (AAD), Randomized, Double-blind, Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT02993419
- Acronym / sponsor ID
- dbzy160801
- Conditions
- Antibiotic-associated Diarrhea
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- Jiangsu Famous Medical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Dec 2016
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Feb 2018 (estimated)
- First posted
- 15 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- MAIN OUTCOME MEASURES: The incidence of diarrhea (stool frequency and character daily rates), the duration of diarrhea, the degree of diarrhea occur.
- Secondary outcomes: intestinal flora and relevant metabolites, micro-environmental changes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bacillus licheniformis Intervention | Experimental | Drug: Bacillus licheniformis InterventionThe 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 |
| placebo Intervention | Placebo comparator | Other: placebo InterventionThe 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 |
Who may qualify
- Ages
- 1 month to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bacillus licheniformis InterventionOn 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 | Drug | Bacillus licheniformis Intervention |
| placebo InterventionOn 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 | Other | placebo Intervention |
Primary outcome
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
1 secondary outcome
Strain type
Time frame: the first day and the seven day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bacillus licheniformis Intervention in people with Antibiotic-associated Diarrhea, run by Jiangsu Famous Medical Technology Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Record daily stool frequency, shape observation excrement (time frame: every day，A total of seven days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2016.