UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052474 |
|---|---|
| Receipt number | R000059864 |
| Scientific Title | A study to evaluate the effects of capsules containing lactic acid bacteria on improving knee joint symptoms |
| Date of disclosure of the study information | 2023/12/31 |
| Last modified on | 2024/04/15 09:38:35 |
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Basic information
Public title
A study to evaluate the effects of capsules containing lactic acid bacteria on improving knee joint symptoms
Acronym
A study to evaluate the effects of capsules containing lactic acid bacteria on improving knee joint symptoms
Scientific Title
A study to evaluate the effects of capsules containing lactic acid bacteria on improving knee joint symptoms
Scientific Title:Acronym
A study to evaluate the effects of capsules containing lactic acid bacteria on improving knee joint symptoms
Region
| Japan |
Condition
Condition
Healthy volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of test food on improving knee joint symptoms
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
VAS
Key secondary outcomes
JKOM, JOA score (knee joint), knee flexion angle, Locomotive syndrome risk test, JLEQ score, Shoulder 36 (V 1.3) score, GSRS score, FSSG score
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 test food 1 for 12 weeks (once a day, 3 capsules)
Interventions/Control_2
Intake of placebo for 12 weeks (once a day, 3 capsules)
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
| 30 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Subjects whose age of 30 years or more and less than 65 years with knee joint pain
2) Subjects diagnosed KL grade 0 or 1 by knee X-ray
3) Subjects receiving a sufficient briefing of the objective and content of the present study, fully understanding and agreeing to voluntarily participate in the study and being able to personally sign a written informed consent
Key exclusion criteria
1) Subjects having a medical history of rheumatism
2) Subjects having leg pain or numbness
3) Subjects having injury of semi-lunar disc or the other knee joint disease
4) Subjects having a present or past history of diseases inducing pain or arthritis, diseases related to cartilage metabolism or bone metabolism (e.g. osteoarthritis, rheumatoid arthritis, osteoporosis)
6) Subjects having a history of visiting an orthopedic surgeon frequently or having a plan to visit an orthopedic surgeon during the study
7) Subjects having a history of visiting osteopathic clinic frequently or having a plan to visit osteopathic clinic during the study
8) Subjects taking supplements or health foods labeled the function to knee joint symptoms (e.g. Foods for Specified Health Uses, Foods with Function Claims)
9) Subjects using medicines or quasi-drugs with the function to knee joint symptoms (e.g. analgesics, anti-inflammatory, vitamin B1 preparations)
10) Subjects taking foods high in lactic acid bacteria or bifidobacterium 3 days or more a week
11) Subjects taking large amounts of foods high in lactic acid bacteria or bifidobacterium
12) Subjects taking lactic acid bacteria or bifidobacterium enriched health foods
13) Subjects taking medicines containing lactic acid bacteria or bifidobacterium as active ingredients(e.g. Biofermin)
14) Subjects having the possibility of developing allergic symptoms by the test food (especially milk and dairy allergy)
15) Female subjects who are pregnant or lactating, or intending to become pregnant during the study
16) Subjects having blood sample of 200 ml or more taken within 1 month, or 400 ml or more within 3 months prior to the start of the present study
17) Subjects who took part in another clinical study within 3 months prior to the start of the present study or who is currently taking part in another clinical study
18) Subjects deemed unsuitable by the investigator
Target sample size
110
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Ueno |
Organization
Megmilk Snow Brand Co., Ltd.
Division name
Milk Science Research Institute
Zip code
350-1165
Address
1-1-2, Minamidai, Kawagoe-shi, Saitama
TEL
049-242-8165
hiroshi-ueno@meg-snow.com
Public contact
Name of contact person
| 1st name | Tomohiro |
| Middle name | |
| Last name | Sugino |
Organization
Soiken Inc.
Division name
R&D Division
Zip code
560-0082
Address
Senri Life Science Center 13F, 1-4-2, Shinsenri-higashimachi, Toyonaka-shi, Osaka
TEL
06-6871-8888
Homepage URL
sugino@soiken.com
Sponsor or person
Institute
Megmilk Snow Brand Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB of Fukuda Clinic
Address
Shin-Osaka brick building 2F, 1-6- 1 Miyahara, Yodogawa-ku, Osaka-shi, Osaka
Tel
06-6398-0203
fukudaclinicIRB@gmail.com
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
| 2023 | Year | 12 | Month | 31 | 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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 09 | Month | 16 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 16 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 04 | Day |
Last follow-up date
| 2024 | Year | 09 | 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
| 2023 | Year | 10 | Month | 12 | Day |
Last modified on
| 2024 | Year | 04 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059864
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