UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Recruitment status Completed
Unique ID issued by UMIN UMIN000008676
Receipt No. R000010193
Scientific Title Effects of lactic acid bacteria-fermented soy milk on the patients with colon polyp - double blind, randomized controlled trial -
Date of disclosure of the study information 2012/08/11
Last modified on 2012/08/11

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Effects of lactic acid bacteria-fermented soy milk on the patients with colon polyp - double blind, randomized controlled trial -
Acronym lactic acid bacteria-fermented soy milk and human colon polyp
Scientific Title Effects of lactic acid bacteria-fermented soy milk on the patients with colon polyp - double blind, randomized controlled trial -
Scientific Title:Acronym lactic acid bacteria-fermented soy milk and human colon polyp
Region
Japan

Condition
Condition colon polyp
Classification by specialty
Medicine in general Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effects of lactic acid bacteria-fermented soy milk on colon polyp and on modulation of immunological response 6 month after the administration.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Findings of colonoscopy
Key secondary outcomes CEA, NK activity, change of defecation, fecal occult blood, AST (GOT), ALT (GPT), POMS, check of brain fatigue

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 The experimental food (the fermented soy milk) was administered to 10 patients with colon polyp 2 times a day for 6 months.
Interventions/Control_2 The control food was administered to 10 patients with colon polyp 2 times a day for 6 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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Persons who take sufficient explanations on the trial and give an agreement in written form
2. Persons over 20 years old in any sex.
3. Persons who was diagnosed as colon polyp by colonoscopy
Key exclusion criteria 1. Persons who showed possible colon cancer
2. Persons who have malignant tumors
3. Persons who have ulcerative colitis
4. Persons who are taking antibiotics or steroid hormone
5. Persons who were judged unqualified by the doctor in charge
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takehiko Fujino
Organization BOOCS Medical Corporation
Division name Director
Zip code
Address 6-18-6F, Tenyamachi, Hakata-ku, Fukuoka-shi Fukuoka 812-0025 Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization BOOCS Medical Corporation
Division name BOOCS Clinic Fukuoka
Zip code
Address 6-18-6F, Tenyamachi, Hakata-ku, Fukuoka-shi F, Tenyhi, Hakata-ku, Fukuoka-shi Fukuoka 812-0025 Japan
TEL 092-283-6852
Homepage URL
Email fujino-t@boocsclinic.com

Sponsor
Institute Bioennet corporation
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization B&S corporation
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
Email

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
2012 Year 08 Month 11 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
2010 Year 10 Month 16 Day
Date of IRB
Anticipated trial start date
2010 Year 10 Month 30 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 08 Month 11 Day
Last modified on
2012 Year 08 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010193


Contact us.