UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053242 |
|---|---|
| Receipt number | R000060757 |
| Scientific Title | A study for safety evaluation of Long-Term intake of Probiotics -A Randomized, Double-Blind, Placebo-Controlled trial- |
| Date of disclosure of the study information | 2024/04/05 |
| Last modified on | 2024/12/27 09:14:59 |
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Basic information
Public title
A study for safety evaluation of Long-Term intake of Probiotics -A Randomized, Double-Blind, Placebo-Controlled trial-
Acronym
A study for safety evaluation of Long-Term intake of Probiotics -A Randomized, Double-Blind, Placebo-Controlled trial-
Scientific Title
A study for safety evaluation of Long-Term intake of Probiotics -A Randomized, Double-Blind, Placebo-Controlled trial-
Scientific Title:Acronym
A study for safety evaluation of Long-Term intake of Probiotics -A Randomized, Double-Blind, Placebo-Controlled trial-
Region
| Japan |
Condition
Condition
Male/female adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the long-term safety of probiotic intake in healthy adult subjects by taking probiotic powder for 12 weeks.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Questionnaire
Physical measurement (height, weight (BMI))
Blood pressure and pulse rate
Hematology
Biochemistry
Urinalysis
Self and other symptoms
Adverse events and side effects
Key secondary outcomes
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
Consumption of the test food (1 sachet a day) for 12 weeks
Interventions/Control_2
Consumption of the placebo food (1 sachet a day) for 12 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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Subjects who are age of at least 18 years of age and less than 65 years.
2.Subjects who received an enough explanation of the test objectives and detail, who have consent ability, who are willing to participate with well understandings and who have signed the informed consent document.
Key exclusion criteria
1.Subjects who have a history of serious illness.
2.Subjects who are under treatment with medication for chronic diseases.
3.Subjects who are unable to discontinue foods or supplements containing lactic acid bacteria, bifidobacteria, oligosaccharides, etc. during the study period.
4.Subjects who have digestive tract diseases that affect digestion and absorption, and have had a history of gastrointestinal surgery (excluding appendicitis).
5.Subjects who are under treatment for or have a history of drug addiction and/or alcoholism.
6.Subjects who are planning to participate in other clinical studies.
7.Subjects with a history of drug allergies or severe food allergies.
8.Subjects who are pregnant or under lactation, or who is expected to be pregnant during the study period.
9.Heavy alcohol drinkers (average of more than 20g of alcohol/day in terms of pure alcohol).
10.Excessive smokers (21 or more cigarettes per day).
11.Subjects who have been diagnosed with dry mouth.
12.Subjects who have had more than 400 mL of blood drawn within 12 weeks prior to the start of intake, or more than 200 mL of blood drawn during the previous observation period.
13.Subjects who have been deemed unsuitable as study participants by the principal investigator or sub-investigator based on their background, physical examination, blood pressure, pulse rate, and clinical test results.
Target sample size
40
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
1-2-70, Konan, Minato-ku, Tokyo The 5th floor of Shinagawa season terrace
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
1-9-7, Shibaura, Minato-ku, Tokyo The 7th floor of Shibaura omodaka building
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
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee of Kobuna Orthopedics Clinic
Address
5-656-17Joutou-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 | 04 | Month | 05 | 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
40
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
| 2023 | Year | 11 | Month | 20 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 20 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 24 | Day |
Last follow-up date
| 2024 | Year | 11 | Month | 02 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 12 | Month | 27 | Day |
Last modified on
| 2024 | Year | 12 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060757
