UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025190 |
|---|---|
| Receipt number | R000028941 |
| Scientific Title | Evaluation study to evaluate the efficacy of food containing Saccharomyces cerevisiae on human intestinal environment |
| Date of disclosure of the study information | 2016/12/17 |
| Last modified on | 2018/03/21 12:40:05 |
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Basic information
Public title
Evaluation study to evaluate the efficacy of food containing Saccharomyces cerevisiae on human intestinal environment
Acronym
Evaluation study to evaluate the efficacy of food containing Saccharomyces cerevisiae on human intestinal environment
Scientific Title
Evaluation study to evaluate the efficacy of food containing Saccharomyces cerevisiae on human intestinal environment
Scientific Title:Acronym
Evaluation study to evaluate the efficacy of food containing Saccharomyces cerevisiae on human intestinal environment
Region
| Japan |
Condition
Condition
Tendency toward constipation
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of food containing Saccharomyces cerevisiae in improving human intestinal environment after continuous intake
Basic objectives2
Safety
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
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Ingestion of peptide for 4 weeks.
Interventions/Control_2
Ingestion of placebo for 4 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 20-64 years old (inclusive)
(2)Subjects with tendency for constipation at 3 to 5 times of defecation per week
(3)Subjects who take 3 meals per day regularly
(4)Willing and able to provide signed written informed consent
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 lactobacillus, 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 life style questionnaire
11)Subjects who had participated in other clinical trials including drug and food within 1 month.
12)Any candidate considered to be unsuitable for enrollment in the opinion of the principal investigator
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yumiko Ide |
Organization
Medical Corporation Chisei-kai Tokyo Center Clinic
Division name
Medical Corporation Chisei-kai Tokyo Center Clinic
Zip code
Address
Yaesu KT Bldg 1-1-8 Yaesu, Chuo-ku, Tokyo
TEL
03-3276-6935
miyake@tc-clinic.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shigeru Imai |
Organization
CROee.INC
Division name
Evidence Division
Zip code
Address
2F YS Build. 1-13-23 Minamiikebukuro Toshima-ku, Tokyo, Japan
TEL
03-5953-2108
Homepage URL
imai@croee.com
Sponsor or person
Institute
CROee.INC
Institute
Department
Personal name
Funding Source
Organization
Nikkenkyo Service Inc.
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 | 12 | Month | 17 | 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
| 2016 | Year | 12 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 12 | Month | 17 | Day |
Last follow-up date
| 2017 | Year | 04 | Month | 08 | Day |
Date of closure to data entry
| 2017 | Year | 05 | Month | 18 | Day |
Date trial data considered complete
| 2017 | Year | 07 | Month | 07 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 12 | Month | 08 | Day |
Last modified on
| 2018 | Year | 03 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028941
