UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043735 |
|---|---|
| Receipt number | R000049936 |
| Scientific Title | Efficacy evaluation of fermented milk drink on healthy adult with poor intestinal health: A double-blind, randomized, placebo-controlled, parallel group study |
| Date of disclosure of the study information | 2022/04/01 |
| Last modified on | 2025/03/31 11:39:51 |
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Basic information
Public title
Efficacy evaluation of a fermented milk drink
Acronym
Efficacy evaluation of a fermented milk drink
Scientific Title
Efficacy evaluation of fermented milk drink on healthy adult with poor intestinal health: A double-blind, randomized, placebo-controlled, parallel group study
Scientific Title:Acronym
Efficacy evaluation of fermented milk drink on healthy adult with poor intestinal health: A double-blind, randomized, placebo-controlled, parallel group study
Region
| Japan |
Condition
Condition
Subjects with poor intestinal health
Classification by specialty
| Gastroenterology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of a fermented milk drink on intestinal environment, microbiota and immunity index of healthy adult with poor intestinal health
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Intestinal environment
Key secondary outcomes
Stool characteristics and symptoms during defecation
Intestinal microbiota
Immunity index
Health conditon
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
Treatment
Type of intervention
| Food |
Interventions/Control_1
Fermented milk drink
1 bottle/day for 16 weeks
Interventions/Control_2
Placebo drink
1 bottle/day for 16 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
Subjects with poor intestinal health
Key exclusion criteria
1. Subjects regularly taking laxatives or drugs effective on digestive systems
2. Subjects taking antibiotics or any drugs affecting on intestinal microbiota
3. Subjects with severe diseases or metabolic diseases regardless under treatment or not
4. Subjects with chronic diseases and taking drug regularly
5. Subject with history of digestive diseases or digestive surgery
6. Subjects regularly taking any functional food products thought to be effective on constipation and immunity
7. Subjects unable to stop taking restricted food such as probiotics, prebiotics and any foods thought to be effective on constipation and immunity during test period
8. Subjects with drug or alcohol addiction, and history of these
9. Subjects regularly drinking a lot of alcohol
10. Subject unable to stop taking alcohol on the day before the screening test or sampling feces
11. Subjects with any food allergies
12. Subjects judged as unsuitable for the study participant on the screening test
13. Subjects participating or willing to participate in any other studies of food, drug and cosmetic
14. Pregnant or lactating women, and those who have possibility to become pregnant during the study period
15. Subjects judged as unsuitable for the study participant by principal investigator from other reasons
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Toru |
| Middle name | |
| Last name | Sagami |
Organization
Shinagawa Season Terrace Health Care Clinic
Division name
Doctor
Zip code
108-0075
Address
The 5th floor of Shinagawa season terrace, 1-2-70, Konan, Minato-ku, Tokyo
TEL
03-3452-3382
shibaura@sempos.or.jp
Public contact
Name of contact person
| 1st name | Eiji |
| Middle name | |
| Last name | Yoshikawa |
Organization
KSO Corporation
Division name
Sales department
Zip code
105-0023
Address
The 7th floor of Shibaura omodaka building, 1-9-7 Shibaura, Minato-ku, Tokyo
TEL
03-3452-7733
Homepage URL
yoshikawa@kso.co.jp
Sponsor or person
Institute
KSO Corporation
Institute
Department
Personal name
Funding Source
Organization
Yakult Honsha 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
Ethical Committee of Nihonbashi Cardiology Clinic
Address
Kyodo building,13-4, Nihonbashi-kodenmacho, Chuo-ku, Tokyo
Tel
03-5641-4133
niho-jimucho@well-sleep.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
| 2022 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Unpublished
Publication of results
Unpublished
Result
URL related to results and publications
Unpublished
Number of participants that the trial has enrolled
90
Results
A placebo-controlled, randomized, double-blind, parallel study was conducted in adults with poor intestinal health. The results showed that continuous consumption of lactobacillus fermented beverages resulted in significant improvement in terms of the number of days of defecation and other parameters.
Results date posted
| 2025 | Year | 03 | Month | 31 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Subjects with a weekly defecation frequency of 3-5 times per week
Participant flow
1)After explaining the study and obtaining written consent to participate in the study, subjects will be interviewed, their height measured, weight measured, blood pressure and pulse rate measured, clinical examination, fecal examination, subject survey form, and one-week subject diary.
2) The investigator will select subjects according to selection and exclusion criteria.
3) Subjects will consume the study beverage for 16 weeks and complete a questionnaire regarding their physical condition.
Adverse events
It was confirmed that there were no safety issues with the consumption of lactic acid bacteria fermented beverages.
Outcome measures
Bowel movement symptoms
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2021 | Year | 01 | Month | 28 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 26 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 08 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2024 | Year | 09 | Month | 01 | Day |
Date trial data considered complete
| 2024 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2024 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 03 | Month | 25 | Day |
Last modified on
| 2025 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049936
