UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052743 |
|---|---|
| Receipt number | R000060178 |
| Scientific Title | A study to evaluate the efficacy of lactic acid bacteria beverages. |
| Date of disclosure of the study information | 2023/11/09 |
| Last modified on | 2023/12/27 09:09:04 |
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Basic information
Public title
A study to evaluate the efficacy of lactic acid bacteria beverages.
Acronym
A study to evaluate the efficacy of lactic acid bacteria beverages.
Scientific Title
A study to evaluate the efficacy of lactic acid bacteria beverages.
Scientific Title:Acronym
A study to evaluate the efficacy of lactic acid bacteria beverages.
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the ability of different lactic acid bacteria beverages to improve intestinal health after four consecutive weeks of intake in adults with a tendency toward constipation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Defecation related survey integrated score (DRSIS)
Key secondary outcomes
(Secondary outcomes)
Stool tests (e.g., stool pH, concentrations of metabolites, gut microbiota)
(Safety evaluation)
Adverse events
Base
Study type
Interventional
Study design
Basic design
Cross-over
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 A intake for 4 weeks-Washout period for 4 weeks-Test food B intake for 4 weeks
Interventions/Control_2
Test food B intake for 4 weeks-Washout period for 4 weeks-Test food A 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.Japanese males and females who are aged 20 years or over and less than 65 years at the time of written informed consent.
2.Subjects who defecate 5 or less than 5 times a week.
3.Subjects who are fully explained the purpose and details of the study, have ability to consent, are volunteering to participate in the study with a full understanding of the explanation, and have consented to participate in the study in writing.
Key exclusion criteria
1.Subjects who routinely use drugs and quasi-drugs that improve intestinal health (e.g., intestinal drugs, constipation remedies [including laxatives]).
2.Subjects who are receiving drugs that affect the intestinal microbiota such as antibiotics.
3.Subjects with serious medical conditions such as diabetes, renal/hepatic impairment and heart disease, thyroid or adrenal gland disease, or other metabolic problems and those who are receiving medical treatment.
4.Subjects who are unable to refrain from eating food products that are known to help relieve constipation (e.g., yogurt, oligosaccharides) during the study period.
5.Subjects who habitually drink more alcohol than the recommended upper limit (i.e., mean daily alcohol consumption of about 40 g of pure alcohol equivalent; for example, two middle-size bottles [1000 mL] of beer).
6.Subjects who are planning to become pregnant after informed consent for the current study or are pregnant or lactating.
7.Subjects at risk for allergic reactions to the material of the test food (milk protein).
8.Subjects receiving exercise or diet therapy under the supervision of physicians.
9.Subjects with current or previous history of drug dependence or alcohol dependence.
10.Subject who is attending a hospital due to mental disorders (depression, etc.) or sleep disorders, or who has a history of mental illness in the past.
11.Night or shift workers with extremely irregular life patterns.
12.Subjects whose eating, sleeping, and other habits are extremely irregular.
13.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.
14.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.
15.Subjects who have difficulty complying with recording of each survey form.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Hidemasa |
| Middle name | |
| Last name | Toya |
Organization
HUMA R&D CORP
Division name
Clinical Development Department
Zip code
108-0014
Address
Round Cross Tamachi 9F, 5-31-19 Shiba, Minato-ku, Tokyo 108-0014 Japan
TEL
03-3431-1260
toya@huma-rd.co.jp
Public contact
Name of contact person
| 1st name | Hidemasa |
| Middle name | |
| Last name | Toya |
Organization
HUMA R&D CORP
Division name
Clinical Development Department
Zip code
108-0014
Address
Round Cross Tamachi 9F, 5-31-19 Shiba, Minato-ku, Tokyo 108-0014 Japan
TEL
03-3431-1260
Homepage URL
toya@huma-rd.co.jp
Sponsor or person
Institute
HUMA R&D CORP
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
Miyake Clinic Institutional Review Board
Address
4-2-17 Komagome, Toshima-ku, Tokyo 170-0003 Japan
Tel
03-6903-7211
jim@medipharma.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
| 2023 | Year | 11 | Month | 09 | 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 | 10 | Month | 11 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 13 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 13 | Day |
Last follow-up date
| 2024 | Year | 04 | Month | 17 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
(Exclusion criteria continued)
16.Subjects whose laboratory test values or measurements at screening indicate their ineligibility to participate in the study.
17.Other Subjects who are considered ineligible for participation in the study by the investigator.
Management information
Registered date
| 2023 | Year | 11 | Month | 09 | Day |
Last modified on
| 2023 | Year | 12 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060178
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
