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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||
Condition | threatened preterm delivery | |
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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 |
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Target sample size | 60 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 | |
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Name of secondary funder(s) |
IRB Contact (For public release) | |
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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 |
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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 | |
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Baseline Characteristics | |
Participant flow | |
Adverse events | |
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Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Terminated | ||||||
Date of protocol fixation |
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Management information | |||||||
Registered date |
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Last modified on |
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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 |