UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056106 |
|---|---|
| Receipt number | R000064107 |
| Scientific Title | A randomized, double-blind, placebo-controlled, parallel-group comparative study of the effects of probiotics on the intestinal environment in healthy subjects. |
| Date of disclosure of the study information | 2024/11/08 |
| Last modified on | 2024/11/08 17:03:19 |
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Basic information
Public title
A randomized, double-blind, placebo-controlled, parallel-group comparative study of the effects of probiotics on the intestinal environment in healthy subjects.
Acronym
A study of the effects of probiotics on the intestinal environment in healthy subjects.
Scientific Title
A randomized, double-blind, placebo-controlled, parallel-group comparative study of the effects of probiotics on the intestinal environment in healthy subjects.
Scientific Title:Acronym
A study of the effects of probiotics on the intestinal environment in healthy subjects.
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of probiotic consumption on the intestinal environment in healthy adults.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Gut metabolites
Key secondary outcomes
Gut microbiota
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
Intake of probiotic yogurt for 14 days
Interventions/Control_2
Intake of placebo yogurt for 14 days
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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Healthy males and females who are aged 18-64 years at the time of obtaining consent.
2. Subjects who fully understand the purpose and content of this study and agree to participate in this study with a written informed consent.
Key exclusion criteria
1. Subjects who regularly take medicines that affect the intestinal environment (antibiotics, bowel medicines, laxatives, etc.).
2. Subjects who regularly take foods or supplements that contain lactic acid bacteria, bifidobacteria or oligosaccharides, or that affect the intestinal environment.
3. Subjects who cannot stop taking health foods, supplements, foods for specified health uses, foods with functional claims, or foods with nutritional function claims.
4. Subjects receiving treatment for serious cancer, respiratory, hepatic, renal, cardiac, lung, gastrointestinal, blood, endocrine or metabolic diseases, or those with a serious history of these diseases.
5. Subjects with a history of digestive tract surgery (except adenoidectomy, appendicitis, etc.).
6. Subjects with serious drug or food allergies or a history of such allergies.
7. Subjects with a milk allergy or lactose intolerance
8. Subjects who are pregnant, lactating, or planning to become pregnant during the study period.
9. Subjects who have a drinking habit or cannot stop drinking during the specified period.
10. Subjects with a smoking habit.
11. Subjects currently taking or planning to take medicine for hay fever or perennial allergies during the study period.
12. Subjects who have participated in other clinical trials within 3 months of consent, or who plan to participate in other clinical trials during this study period.
13. Subjects who are judged ineligible to this study by principal investigator.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Tsuge |
Organization
Shinagawa Season Terrace Health Care Clinic
Division name
Doctor
Zip code
108-0075
Address
Shinagawa Season Terrace 5F, 1-2-70 Konan, Minato-ku, Tokyo 108-0075
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
Clinical Trial Management department
Zip code
105-0023
Address
Shibaura Omodaka Building 7F, 1-9-7 Shibaura, Minato-ku, Tokyo 105-0023
TEL
03-3452-7733
Homepage URL
eigyou27@kso.co.jp
Sponsor or person
Institute
KSO corporation
Institute
Department
Personal name
Funding Source
Organization
Morinaga Milk Industry CO., LTD.
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
Ethical Committee of Kobuna Orthopedics Clinic
Address
5-656-17 Joutou-machi,Maebashi-shi,Gunma
Tel
027-212-5608
sagawa@mc-connect.co.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 | 11 | Month | 08 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 11 | Month | 07 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 07 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 25 | Day |
Last follow-up date
| 2025 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 11 | Month | 08 | Day |
Last modified on
| 2024 | Year | 11 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064107
