UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	An exploratory trial about the efficacy of lactobacillus A and substance B on endometriosis
Title of the study (Brief title)	An exploratory trial about the efficacy of lactobacillus A and substance B on endometriosis
Region	Japan

Condition
Condition	endometriosis
Classification by specialty	Obsterics and gynecology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effect on endometriosis and safety of Lactobacillus A and substance B.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Pain is assessed with VAS. The average score of menstrual pain when combination drug is used is compared with that of menstrual pain when single drug is used
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Active
Stratification	NO
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	combination drug is administarated for 3 months
Interventions/Control_2	single drug is administarated for 3 months
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	Not applicable
Age-upper limit	Not applicable
Gender	Female
Key inclusion criteria	1 patients who obtained the diagnosis of endometriosis 1-1 Past history of operation for endometriosis. diagnosed pathologically or surgical findings with the observation at the operation. 1-2 The patient diagnosed endometriosis by an internal exam or ultrasound exam 2 The menstrual cycle is within 25-31days low dose EP is unconcerned. 3 Use at least one dose of painkiller dualing the time of menstrual periods.
Key exclusion criteria	1) have severe asthma or allergy to multiple drugs 2) has diarrhea by uptake of dairy goods 3) have past history of allergy to dairy products 4) cervical cytology worse than class 2 5) have carcinoma 6) severe hepatic or renal damage or have past history of cardiac infarct 7) past history of hepatitis 8) severe anemia 9) appropriate judged by responsible doctor
Target sample size	30

Research contact person
Name of lead principal investigator	TAKAMURA MASASHI
Organization	University of Tokyo
Division name	Obstetrics and Gynecology
Address	7-3-1 Hongo Bunkyo Tokyo, Japan
TEL	03-3815-5411
Email	takamura-tky@umin.ac.jp

Public contact
Name of contact person	TAKAMURA MASASHI
Organization	University of Tokyo
Division name	Obstetrics and Gynecology
Address	7-3-1 Hongo Bunkyo Tokyo, Japan
TEL	03-3815-5411
Homepage URL
Email	takamura-tky@umin.ac.jp

Sponsor
Institute	The University of Tokyo Hospital
Institute
Department

Funding Source
Organization	Meiji co., Ltd
Organization
Division
Category of Funding Organization	Profit 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	東京大学病院

Other administrative information
Date of disclosure of the study information	2015 Year 05 Month 31 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 03 Month 22 Day
Anticipated trial start date	2015 Year 06 Month 01 Day
Last follow-up date	2017 Year 09 Month 30 Day
Date of closure to data entry	2017 Year 12 Month 31 Day
Date trial data considered complete	2017 Year 12 Month 31 Day
Date analysis concluded	2018 Year 03 Month 31 Day

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

Management information
Registered date	2015 Year 05 Month 12 Day
Last modified on	2017 Year 11 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020146