UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016860 |
|---|---|
| Receipt number | R000019571 |
| Scientific Title | Comparison examination of microbiota in mouth, intestine and vagina before and after medication of a raw bacillus agent (an active bacterial probiotics, Bio-Three) to the threatened premature delivery patient who requires in-hospital treatment, and examination about validity of preterm delivery medical treatment |
| Date of disclosure of the study information | 2015/03/21 |
| Last modified on | 2017/12/11 14:28:48 |
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Basic information
Public title
Comparison examination of microbiota in mouth, intestine and vagina before and after medication of a raw bacillus agent (an active bacterial probiotics, Bio-Three) to the threatened premature delivery patient who requires in-hospital treatment, and examination about validity of preterm delivery medical treatment
Acronym
Comparison examination of microbiota in mouth, intestine and vagina before and after medication of a raw bacillus agent to threatened preterm delivery, and examination about validity of preterm delivery medical treatment
Scientific Title
Comparison examination of microbiota in mouth, intestine and vagina before and after medication of a raw bacillus agent (an active bacterial probiotics, Bio-Three) to the threatened premature delivery patient who requires in-hospital treatment, and examination about validity of preterm delivery medical treatment
Scientific Title:Acronym
Comparison examination of microbiota in mouth, intestine and vagina before and after medication of a raw bacillus agent to threatened preterm delivery, and examination about validity of preterm delivery medical treatment
Region
| Japan |
Condition
Condition
threatened preterm delivery
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To perform a raw bacillus agent (Bio-Three®, 6 tablets per day) medication to patients of threatened preterm delivery who need in-hospital treatment and
To evaluate a change of microbiota in mouth, intestine and vagina before and after medication by the T-RFLP (Terminal restriction fragment length polymorphism) method and meta-genomics analysis using a next-generation sequencer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
a change of microbiota in mouth, intestine and vagina
Key secondary outcomes
Base
Study type
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
A raw bacillus agent (Bio-Three 6 tablets per day, 14 days) is prescribed.
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
a patient of threatened preterm delivery (tocolysis index, 2 to 6) who needs in-hospital treatment, who was transferred from other hospitals or was out-patient in our hospital at 22 to 34 weeks of gestation
Key exclusion criteria
1) multiple pregnancy
2) previous medication of antibiotics within 14 days
3) premature rupture of the membranes
4) tocolysis index of 7 or higher (there is a possibility of becoming a preterm delivery within one week)
5) allergy to Bio-Three
6) ulcerative colitis and Crohn's disease
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigeru Saito |
Organization
University of Toyama
Division name
OB/GYN
Zip code
Address
2630 Sugitani Toyama
TEL
076-434-7355
s30saito@med.u-toyama.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Arihiro Shiozaki |
Organization
University of Toyama
Division name
Obstetrics and Gynecology
Zip code
Address
2630 Sugitani, Toyama
TEL
076-434-7357
Homepage URL
s33shio@med.u-toyama.ac.jp
Sponsor or person
Institute
University of Toyama
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
| 2015 | Year | 03 | Month | 21 | 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
Terminated
Date of protocol fixation
| 2014 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 03 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 03 | Month | 21 | Day |
Last modified on
| 2017 | Year | 12 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019571
