UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief title)	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	Shigeru Saito
Organization	University of Toyama
Division name	OB/GYN
Address	2630 Sugitani Toyama
TEL	076-434-7355
Email	s30saito@med.u-toyama.ac.jp

Public contact
Name of contact person	Arihiro Shiozaki
Organization	University of Toyama
Division name	Obstetrics and Gynecology
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2014 Year 01 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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