UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006261 |
|---|---|
| Receipt number | R000007122 |
| Scientific Title | Analysis for the change of the intestinal bacterial flora by antimicrobials (antibiotics) with using T-RFLP method, and examination of the usefulness of probiotics for diarrhea caused by antimicrobials. |
| Date of disclosure of the study information | 2011/09/01 |
| Last modified on | 2011/08/31 15:35:31 |
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Basic information
Public title
Analysis for the change of the intestinal bacterial flora by antimicrobials (antibiotics) with using T-RFLP method, and examination of the usefulness of probiotics for diarrhea caused by antimicrobials.
Acronym
Analysis for the change of the intestinal bacterial flora by antimicrobials (antibiotics) with using T-RFLP method, and examination of the usefulness of probiotics for diarrhea caused by antimicrobials.
Scientific Title
Analysis for the change of the intestinal bacterial flora by antimicrobials (antibiotics) with using T-RFLP method, and examination of the usefulness of probiotics for diarrhea caused by antimicrobials.
Scientific Title:Acronym
Analysis for the change of the intestinal bacterial flora by antimicrobials (antibiotics) with using T-RFLP method, and examination of the usefulness of probiotics for diarrhea caused by antimicrobials.
Region
| Japan |
Condition
Condition
Patients with nonsevere of acute pharyngitis, acute bronchitis, otitis media, etc. who need antimicrobials treatment.
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To analyze the change of the intestinal bacterial flora by T-RFLP method for children treated by antimicrobials, and
to examine clinical usefulness of Bio-Three for diarrhea caused by antimicrobials by comparing with non-administration group as control.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of diarrhea
Key secondary outcomes
Analysis of the intestinal bacterial flora by T-RFLP method
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Probiotics administration group : Bio-Three powder or Bio-Tree tablets
6 months ~ less than 3 years : 0.5g t.i.d or 1 tablet t.i.d
3 years ~ less than 15 years : 1.0g t.i.d or 2 tablets t.i.d
Interventions/Control_2
Non probiotics administration group
(conventional therapy only)
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 6 | months-old | <= |
Age-upper limit
| 180 | months-old | > |
Gender
Male and Female
Key inclusion criteria
1.Patients with nonsevere of acute pharyngitis, acute bronchitis, otitis media, etc. who need antimicrobials treatment.
2.Patients whose representatives have submitted the letter of consent.
3.Patients who can observe this protocol.
Key exclusion criteria
1.Patients with diarrhea before administration.
2.Patients who received antimicrobials administration within one week before administration.
3.Patients with chronic, immunity system and serious diseases.
4.Patients who are applicable for chemotherapy, immunostimulation therapy, radiotherapy or surgery.
5.Patients with critical liver and kidney disorders and heart diseases, which may affect drug safety.
6.Patients with drug allergy.
7.Others; Patients who are judged as inappropriate for this test by lead principal investigator or contributing investigators.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toru Igarashi |
Organization
Nippon Medical School Hospital
Division name
Department of Pediatric
Zip code
Address
1-1-5 Sendagi, Bunkyo-ku, Tokyo, Japan
TEL
03-3822-2131
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toru Igarashi |
Organization
Nippon Medical School Hospital
Division name
Department of Pediatrics
Zip code
Address
1-1-5 Sendagi, Bunkyo-ku, Tokyo, Japan
TEL
03-3822-2131
Homepage URL
iga@nms.ac.jp
Sponsor or person
Institute
Nippon Medical School Hospital
Department of Pediatric
Institute
Department
Personal name
Funding Source
Organization
Toa Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2011 | Year | 02 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 08 | Month | 31 | Day |
Last modified on
| 2011 | Year | 08 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007122
