UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017530 |
|---|---|
| Receipt number | R000020146 |
| Scientific Title | An exploratory trial about the efficacy of lactobacillus A and substance B on endometriosis |
| Date of disclosure of the study information | 2015/05/31 |
| Last modified on | 2017/11/12 09:32:51 |
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Basic information
Public title
An exploratory trial about the efficacy of lactobacillus A and substance B on endometriosis
Acronym
An exploratory trial about the efficacy of lactobacillus A and substance B on endometriosis
Scientific Title
An exploratory trial about the efficacy of lactobacillus A and substance B on endometriosis
Scientific Title:Acronym
An exploratory trial about the efficacy of lactobacillus A and substance B on endometriosis
Region
| Japan |
Condition
Condition
endometriosis
Classification by specialty
| Obstetrics 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
| 1st name | |
| Middle name | |
| Last name | TAKAMURA MASASHI |
Organization
University of Tokyo
Division name
Obstetrics and Gynecology
Zip code
Address
7-3-1 Hongo Bunkyo Tokyo, Japan
TEL
03-3815-5411
takamura-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | TAKAMURA MASASHI |
Organization
University of Tokyo
Division name
Obstetrics and Gynecology
Zip code
Address
7-3-1 Hongo Bunkyo Tokyo, Japan
TEL
03-3815-5411
Homepage URL
takamura-tky@umin.ac.jp
Sponsor or person
Institute
The University of Tokyo Hospital
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
Completed
Date of protocol fixation
| 2015 | Year | 03 | Month | 22 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020146
