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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000032411
Receipt No. R000036956
Scientific Title Verification test of the effect of lactic acid bacterium containing foods intake on functions of the intestines.
Date of disclosure of the study information 2018/06/01
Last modified on 2018/10/29

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Basic information
Public title Verification test of the effect of lactic acid bacterium containing foods intake on functions of the intestines.
Acronym Verification test of the effect of lactic acid bacterium containing foods intake on functions of the intestines.
Scientific Title Verification test of the effect of lactic acid bacterium containing foods intake on functions of the intestines.
Scientific Title:Acronym Verification test of the effect of lactic acid bacterium containing foods intake on functions of the intestines.
Region
Japan

Condition
Condition Healthy adult
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the effect of the test food on the regulation of intestinal function in constipation-prone men and women aged 20 to 65 years.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Intestinal flora , Defecation frequency, Fecal amount , Bristol Stool Form Scale
Key secondary outcomes Vital signs

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
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 2-week intake of the test food
Wash out
2-week intake of the placebo
Interventions/Control_2 2-week intake of the placebo
Wash out
2-week intake of the test food
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)Age: 20 years or older, under 65 years of age
2)Gender: Japanese males and females
3)Persons who have had 3 to 5 bowel movements per week
Key exclusion criteria 1)People who regularly drink or drink yogurt containing lactobacilli*Yogurt consumption will not be excluded if habit exists during the study.
2)Patients who cannot limit the use of drugs that may affect bowel movements (e.g., laxatives, intestinal regulators), health foods, specified health foods, functional labeling foods, health .
3)Subjects who were attending the hospital for bowel movements illness at study entry and were taking medications or taking over-the-counter laxatives.
4)Persons who are currently receiving treatment at a medical institution for gastrointestinal diseases that have an effect on the regulation of intestinal function, or those who have undergone.
5)Persons with or with a history of diseases that may significantly affect bowel movements, such as irritable bowel disease and ulcerative colitis.
6)Persons with or with a history of diseases such as diabetes, liver disease, kidney disease, or heart disease.
7)Persons currently undergoing exercise and diet therapy under the supervision of a physician.
8)Persons with diseases requiring constant medication.
9)Persons with a history of serious disease requiring medical treatment.
10)Persons with a history of drug or food allergy.
11)Subjects who are judged inappropriate as subjects based on the responses to the background questionnaire.
12)Subjects with significant deviations from reference ranges in pre-test physical, physical, and laboratory measurements.
13)Pregnant, lactating women, or women who wish to become pregnant during the study.
14)Persons with a current or past history of psychiatric disorders (e.g., depression).
15)Persons who work shift, such as night shift workers.
16)Patients who are receiving or have a history of drug dependence or drug abuse.
17)Individuals who have participated in other human clinical studies or are currently participating in other human clinical studies within the past 3 months.
18)Other subjects who are considered inappropriate as subjects by the investigator.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ochitani Daisuke
Organization HUMA R&D CORP
Division name Clinical Development Division
Zip code
Address Round Cross Tamachi 10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
TEL 81-3-3431-1260
Email ochitani@huma-c.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ochitani Daisuke
Organization HUMA R&D CORP
Division name Clinical Development Division
Zip code
Address Round Cross Tamachi 10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
TEL 81-3-3431-1260
Homepage URL
Email ochitani@huma-c.co.jp

Sponsor
Institute HUMA R&D CORP
Institute
Department

Funding Source
Organization Pickles corporation
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
2018 Year 06 Month 01 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
2018 Year 04 Month 13 Day
Date of IRB
Anticipated trial start date
2018 Year 06 Month 01 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
2018 Year 04 Month 27 Day
Last modified on
2018 Year 10 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036956

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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