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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000016860
Receipt No. 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

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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
Obsterics 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
Email 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
Email s33shio@med.u-toyama.ac.jp

Sponsor
Institute University of Toyama
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019571

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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