UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038057 |
|---|---|
| Receipt number | R000043377 |
| Scientific Title | Confirmatory study to evaluate the efficacy of food on human intestinal environment |
| Date of disclosure of the study information | 2019/09/20 |
| Last modified on | 2020/07/29 14:09:10 |
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Basic information
Public title
Confirmatory study to evaluate the efficacy of food on human intestinal environment
Acronym
Confirmatory study to evaluate the efficacy of food on human intestinal environment
Scientific Title
Confirmatory study to evaluate the efficacy of food on human intestinal environment
Scientific Title:Acronym
Confirmatory study to evaluate the efficacy of food on human intestinal environment
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of food containing lactobacillus P compared to placebo in improving human intestinal environment after continuous intake
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Intestinal flora analysis
Key secondary outcomes
Defecation frequency
Defecation days
Questionnaire on sleeping quality (OSA inventory-MA version)
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
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Ingestion of test beverage (8 weeks)
Interventions/Control_2
Ingestion of control beverage (8 weeks)
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Japanese male and female ages 20-65 years old (inclusive)
2) Subjects with tendency for constipation at 3 to 5 times of defecation per week
3) Subjects who competent to consent and give voluntary consent in writing with full understanding after receiving explanation of this study aim and contents
Key exclusion criteria
1) Subjects with severe hepatic, renal, cardiac, pulmonary, gastrointestinal, hematologic, endocrine and metabolic diseases / disorders
2) Subjects who suffer from diseases/ disorders with continuous medical treatment or with medical history of severe diseases/ disorders needed medical treatment
3) Subjects who suffer from diseases/ disorders that affects the study and are receiving medical treatment from medical institution or have surgical history of digestive system (except appendectomy)
4) Subjects who suffer from diseases/ disorders that affects bowel movement such as irritable bowel syndrome or ulcerative colitis etc. or have medical history of above-mentioned diseases/ disorders
5) Subjects with history of sensitivity to the ingredients
6) Pregnant, lactating women or willing to be pregnancy during the study
7) Subjects who take any kind of medicine (laxative, intestinal drug etc.) that possibly affect bowel movement
8) Subjects who take supplements and/or functional foods (including Food for Specified Health Uses [FOSHU]) regularly that possibly affect bowel movement
9) Subjects who have a habit of eating lactic fermenting beverage or food or Lactobacillus preparation that contain many lactobacilli, food fortified with dietary fiber and/or oligosaccharide 3 and more times per week
10) Any candidate considered to be unsuitable for enrollment based on his/her answers of lifestyle questionnaire
11) Subjects who had participated in other clinical trials including drug and food within 1 month.
12) Subjects who are judged as inappropriate by investigators
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yumiko |
| Middle name | |
| Last name | Ide |
Organization
Medical Corporation Chisei-kai Tokyo Center Clinic
Division name
Medical Corporation Chisei-kai Tokyo Center Clinic
Zip code
105-0004
Address
Yaesu KT Bldg 1-1-8 Yaesu, Chuo-ku, Tokyo
TEL
03-3276-6935
imai@levbrain.com
Public contact
Name of contact person
| 1st name | Shigeru |
| Middle name | |
| Last name | Imai |
Organization
Leverage Brain Inc.
Division name
Clinical Trial Department
Zip code
153-0053
Address
Gohongi 3-13-16 Meguro-ku, Tokyo, Japan
TEL
080-7290-0404
Homepage URL
imai@levbrain.com
Sponsor or person
Institute
Leverage Brain Inc.
Institute
Department
Personal name
Funding Source
Organization
Miyama 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
Japan Conference of Clinical Research
Address
1-13-23 Minamiikebukuro Toshima-ku, Tokyo, Japan
Tel
03-6868-7022
jccr-info@cts-smo.com
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
医療法人社団 知正会 東京センタークリニック（東京都）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 09 | Month | 20 | 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
60
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
| 2019 | Year | 09 | Month | 05 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 20 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 21 | Day |
Last follow-up date
| 2020 | Year | 04 | Month | 15 | Day |
Date of closure to data entry
| 2020 | Year | 04 | Month | 18 | Day |
Date trial data considered complete
| 2020 | Year | 04 | Month | 20 | Day |
Date analysis concluded
| 2020 | Year | 06 | Month | 29 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 09 | Month | 19 | Day |
Last modified on
| 2020 | Year | 07 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043377
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