UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The explorative clinical trial of a medicine for treatment of CIN (Cervical Intraepithelial Neoplasia) using lactobacillus to HPV16 positive CIN 2.
Title of the study (Brief title)	The explorative clinical trial of a medicine for treatment of CIN using lactobacillus to CIN2.
Region	Japan

Condition
Condition	Cervical Intraepithelial Neoplasia 2 (CIN2)
Classification by specialty	Obsterics and gynecology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	It aims at the first drug therapy to CIN2 by inducing the mucosal cellular immunity to HPV oncoprotein E7 with the oral vaccine using lactobacillus.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Clinical efficacy and safety
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine Vaccine
Interventions/Control_1	The CIN therapeutic vaccine or placebo will be taken in 20 days (1st~5th, 8th~12th, 22nd~26th and 50th~54th day) within all administering period (8 weeks). The dosage is assumed to be 4 capsules/time/a day.
Interventions/Control_2	The placebo will be taken in 20 days (1st~5th, 8th~12th, 22nd~26th and 50th~54th day) within all administering period (8 weeks). The dosage is assumed to be 4 capsules/time/a day.
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	50 years-old >
Gender	Female
Key inclusion criteria	1) HPV16 infected women 2) whom can observe all lesioned part by colposcopic inspection 3) patients were diagnosed with CIN2 histologically and judged that follow-up is necessary 4) whom of 20 ~ 50 years old when agreement is acquired. 5) outpatient 6) All patients were required to provide written informed consent.
Key exclusion criteria	1) Person who has obviously received prohibition of using together medicine (treatment) that causes person and immune suppression that has disease that abnormality is found in immune function 2) patients of SCC in cervical cytology. 3) whom hope for laser ablation or conization of the cervix 4) patients with serious acute illness 5) patients that there are previous histories of hypersensitivity in lactobacillus content food (yogurt etc.) and preparation of lactobacillus 6) patients who has allergy for milk 7) pregnant or expected to be pregnant 8) breast feeding mother 9) whom administered other trial drugs within three months before initiation of this trial study 10) whom administered this medicine 11) whom the investigator think inappropriate as a candidate.
Target sample size	40

Research contact person
Name of lead principal investigator	Kei Kawana
Organization	The University of Tokyo Hospital
Division name	Department of Obstetrics & Gynecology
Address	7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL	03-3815-5411(ext.33407)
Email	kkawana-tky@umin.org

Public contact
Name of contact person	Kei Kawana
Organization	The University of Tokyo Hospital
Division name	Department of Obstetrics & Gynecology
Address	7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL	03-3815-5411(ext.33407)
Homepage URL
Email	kkawana-tky@umin.org

Sponsor
Institute	The University of Tokyo Hospital Department of Obstetrics & Gynecology
Institute
Department

Funding Source
Organization	MHLW
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

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	東京大学医学部附属病院（東京都）

Other administrative information
Date of disclosure of the study information	2013 Year 12 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 10 Month 30 Day
Anticipated trial start date	2013 Year 12 Month 10 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	2013 Year 11 Month 07 Day
Last modified on	2017 Year 12 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000014302