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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025190
Receipt No. 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

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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
Email 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
Email imai@croee.com

Sponsor
Institute CROee.INC
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028941

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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