UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021097 |
|---|---|
| Receipt number | R000024203 |
| Scientific Title | A clinical study for evaluating the effects of lactic acid bacteria FK-23 on controlling intestinal functions (improvement of bowel movement) |
| Date of disclosure of the study information | 2016/05/31 |
| Last modified on | 2019/02/21 13:04:17 |
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Basic information
Public title
A clinical study for evaluating the effects of lactic acid bacteria FK-23 on controlling intestinal functions (improvement of bowel movement)
Acronym
A clinical study for evaluating the effects of lactic acid bacteria FK-23 on controlling intestinal functions (improvement of bowel movement)
Scientific Title
A clinical study for evaluating the effects of lactic acid bacteria FK-23 on controlling intestinal functions (improvement of bowel movement)
Scientific Title:Acronym
A clinical study for evaluating the effects of lactic acid bacteria FK-23 on controlling intestinal functions (improvement of bowel movement)
Region
| Japan |
Condition
Condition
Healthy volunteers
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of 2-week intake of lactic acid bacteria FK-23 on controlling intestinal functions in healthy volunteers with a tendency to be constipated
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Defecation frequency
Key secondary outcomes
Population of bifidobacterium to total bacteria, feeling after defecation, smell of feces, defecation days, fecal condition
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
4
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Powder food containing FK-23 (0.25 g)
Interventions/Control_2
Powder food containing FK-23 (0.075 g)
Interventions/Control_3
Powder food containing FK-23 (0.025 g)
Interventions/Control_4
Powder food not containing FK-23 (placebo)
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Healthy subject within 20-65 years of age, both genders, with constipation tendency (with defecation frequency from 3 to 5 times per week)
2)Subject having a briefing of the content of the present study, fully understanding and agreeing to its objective and being able to personally sign a written informed consent
Key exclusion criteria
1)Subject receiving treatment for gastrointestinal diseases
2)Subject having a medical history with organic constipation or irritable bowel syndrome
3)Subject taken medicines for intestinal disorder or laxatives
4)Subject taking medicine, quasi-drugs, food for specified health uses or foods with functional claims having the effects for intestinal functions
5)Subject having serious liver diseases, cardiovascular, respiratory, endocrine or metabolic disorders, or having a medical history with them
6)Subject have a medical history with test food-ralated allergy
7)Female subject who is pregnant or lactating, or intending to become pregnant during the study
8)Subject who took part in another clinical study within 3 months prior to the start of the present study or who is currently taking part in another clinical study
9)Subject deemed unsuitable by the investigator
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Osami Kajimoto |
Organization
Osaka City University Graduate School of Medicine
Division name
Department of Medical Science on Fatigue
Zip code
Address
1-4-3 Asahi-machi, Abeno-ku, Osaka
TEL
06-6645-6171
kajimoto@med.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomohiro Sugino |
Organization
Soiken Inc.
Division name
R&D Division
Zip code
Address
Senri Life Science Center 13F, 1-4-2, Shinsenri-higashimachi, Toyonaka, Osaka
TEL
06-6871-8888
Homepage URL
sugino@soiken.com
Sponsor or person
Institute
Soiken Inc.
Institute
Department
Personal name
Funding Source
Organization
Nichinichi Pharmaceutical 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
Other administrative information
Date of disclosure of the study information
| 2016 | 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 | 12 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 02 | Month | 20 | 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
| 2016 | Year | 02 | Month | 19 | Day |
Last modified on
| 2019 | Year | 02 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024203
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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