UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055322 |
|---|---|
| Receipt number | R000062998 |
| Scientific Title | Clinical evaluation of the intestinal regulating effects of probiotics intake |
| Date of disclosure of the study information | 2024/08/23 |
| Last modified on | 2025/07/25 17:37:02 |
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Basic information
Public title
Clinical evaluation of the intestinal regulating effects of probiotics intake
Acronym
Clinical evaluation of the intestinal regulating effects of probiotics intake
Scientific Title
Clinical evaluation of the intestinal regulating effects of probiotics intake
Scientific Title:Acronym
Clinical evaluation of the intestinal regulating effects of probiotics intake
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the bowel-regulating effect including improvement in bowel movements in healthy adult men and women taking the test food for 4 weeks.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fecal frequency
Key secondary outcomes
(Secondary outcomes)
Fecal characteristics, Gastrointestinal symptoms
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
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Test food intake for 4 weeks
Interventions/Control_2
Placebo food intake 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.Healthy adult who aged 20 years or older and younger than 65 years
2.Subjects with feces frequency 2-5 times / week
Key exclusion criteria
1.Subjects diagnosed with constipated by a physician.
2.Subjects with chronic conditions such as brain disease, malignancies, gastrointestinal, immunological, and respiratory diseases, diabetes mellitus, liver disease (hepatitis), and kidney, heart, thyroid, adrenal, and metabolic diseases, and subjects who currently have or previously had serious manifestations of these conditions.
3.Subjects who routinely use from using medicines or quasi-drugs that affect bowel control, such as bowel regulators, laxatives and laxatives.
4.Subjects who habitually consume yogurt, natural cheese, kefir, lactic acid bacteria beverages, supplements or syrups containing bifidobacteria, lactobacilli, oligosaccharides, etc., or Foods with Function Claims or Foods for Specified Health Uses containing oligosaccharides as a functional substance.
5.Subjects who are unable to stop using medicines, quasi-drugs, foods or supplements that affect bowel regulators during the study period.
6.Subjects receiving medication or outpatient treatment for a disease.
7.Subjects who are at risk of having allergic reactions to drugs or foods.
8.Subjects with current or previous history of drug dependence or alcohol dependence.
9.Heavy users of alcohol (the mean consumption of pure alcohol is 60 g/day or more).
10.Subjects receiving exercise or diet therapy under the supervision of a physician.
11.Subjects who have extremely irregular life rhythms due to night work, shift work, etc.
12.Subjects whose eating, sleeping, and other habits are extremely irregular.
13.Subjects who are having a very unbalanced diet.
14.Smoker
15.Subjects who are currently pregnant or lactating, may become pregnant during the study period.
16.Subjects who participated in another clinical study/research within 3 months before the date of informed consent or who plan to participate in another clinical study/research during the study period.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Miyazawa |
Organization
HUMA R&D CORP
Division name
Clinical Development Department
Zip code
108-0023
Address
NAKANO SPRING Bld 5F, 4-11-17 Shibaura, Minato-ku, Tokyo Japan
TEL
03-3431-1260
rd@huma-rd.co.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Miyazawa |
Organization
HUMA R&D CORP
Division name
Clinical Development Department
Zip code
108-0023
Address
NAKANO SPRING Bld 5F, 4-11-17 Shibaura, Minato-ku, Tokyo 108-0023 Japan
TEL
03-3431-1260
Homepage URL
rd@huma-rd.co.jp
Sponsor or person
Institute
HUMA R&D CORP
Institute
Department
Personal name
Funding Source
Organization
Morinaga Milk Industry 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
Medical Corporation Taifukukai, Osaka Nishiumeda Clinic
Address
Maruito Nishi-Umeda Building 3F, 3-3-45 Umeda Kita-ku, Osaka-shi, Osaka 530-0001 Japan
Tel
06-4797-5660
kanri@ml.taifukukai.jp
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
| 2024 | Year | 08 | Month | 23 | 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
80
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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 05 | Month | 30 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 28 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 26 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 13 | Day |
Date of closure to data entry
| 2025 | Year | 03 | Month | 04 | Day |
Date trial data considered complete
| 2025 | Year | 03 | Month | 28 | Day |
Date analysis concluded
| 2026 | Year | 03 | Month | 31 | Day |
Other
Other related information
(Exclusion criteria continued)
17.Subjects who donated more than 200 mL of whole blood, plasma, or platelets within 1 month before the date of informed consent or 400 mL within 3 months before the date of informed consent.
18.Subjects who have difficulty complying with recording of each survey form.
19.Subjects who have been deemed unsuitable as study participants by the principal investigator based on their background, physical examination, medical examination, and clinical test results.
Management information
Registered date
| 2024 | Year | 08 | Month | 23 | Day |
Last modified on
| 2025 | Year | 07 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062998
