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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020476
Receipt No. R000023654
Scientific Title Single center, double-blind, randomized, parallel trial to evaluate the efficacy of food containing yeast on human gastrointestinal function
Date of disclosure of the study information 2016/01/07
Last modified on 2018/03/21

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Basic information
Public title Single center, double-blind, randomized, parallel trial to evaluate the efficacy of food containing yeast on human gastrointestinal function
Acronym Evaluation study of the efficacy on human gastrointestinal function
Scientific Title Single center, double-blind, randomized, parallel trial to evaluate the efficacy of food containing yeast on human gastrointestinal function
Scientific Title:Acronym Evaluation study of the efficacy on human gastrointestinal function
Region
Japan

Condition
Condition Slight constipation
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To evaluate the efficacy of food containing yeast in improving constipation after 12-week intake
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Defecation frequency, defecation days(After intervention 11-12 weeks after)
Key secondary outcomes Amount of defection, fecal condition(form, color, smell, feeling after defecation)

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 YES
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 food containing yeast 12-week intake(Three times a day intake)
Interventions/Control_2 Placebo 12-week intake(Three times a day intake)
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 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shukuko Ebihara
Organization Chiyoda Paramedical Care Clinic
Division name Chiyoda Paramedical Care Clinic
Zip code
Address 3-3-5 Uchikanda, Chiyoda-ku, Tokyo
TEL 03-5297-5548
Email m.n@cpcc.co.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 1-13-23 Minami-Ikebukuro, Toshima-ku, Tokyo
TEL 03-5953-2108
Homepage URL
Email imai@croee.com

Sponsor
Institute Prime Biz Corporation
Institute
Department

Funding Source
Organization Prime Biz Corporation
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

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 チヨダパラメディカルケアクリニック(東京都)

Other administrative information
Date of disclosure of the study information
2016 Year 01 Month 07 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 11 Month 30 Day
Date of IRB
Anticipated trial start date
2016 Year 01 Month 08 Day
Last follow-up date
2016 Year 04 Month 30 Day
Date of closure to data entry
2016 Year 06 Month 30 Day
Date trial data considered complete
2016 Year 08 Month 04 Day
Date analysis concluded
2016 Year 10 Month 30 Day

Other
Other related information

Management information
Registered date
2016 Year 01 Month 07 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=R000023654

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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