UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056747 |
|---|---|
| Receipt number | R000064395 |
| Scientific Title | Safety Confirmation Study of Excessive Intake of Lactobacillus acidophilus -A randomized, double-blind, placebo-controlled, parallel-group study- |
| Date of disclosure of the study information | 2025/01/19 |
| Last modified on | 2024/12/06 10:30:17 |
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Basic information
Public title
Safety Confirmation Study of Excessive Intake of Lactobacillus acidophilus
-A randomized, double-blind, placebo-controlled, parallel-group study-
Acronym
Safety Confirmation Study of Excessive Intake of Lactobacillus acidophilus
Scientific Title
Safety Confirmation Study of Excessive Intake of Lactobacillus acidophilus
-A randomized, double-blind, placebo-controlled, parallel-group study-
Scientific Title:Acronym
Safety Confirmation Study of Excessive Intake of Lactobacillus acidophilus
Region
| Japan |
Condition
Condition
No
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective is to evaluate the safety of the test food in healthy adult subjects when consumed in excess amounts.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Existence and its contents of side effects: expression number and expression rate of side effects (expression rate: number of cases/number of cases analyzed)
(Pre-intake, 2 weeks and 4 weeks after intake, and 2 weeks after the end of intake of test food)
Key secondary outcomes
1)Adverse events: number of cases and expression rate of adverse events (expression rate: number of cases/number of cases analyzed)
2)Physical xamination
3)Clinical examination
4)Doctor's questions
5)Exploratory study
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
Oral intake of the test food (1 bottle in a day; 4 weeks).
Interventions/Control_2
Oral intake of the placebo food (1 bottle in a day; 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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Age between 18 and 65 years old at the time of obtaining consent to participate in the study.
2) Individuals who have been fully informed of the purpose and content of the study, have the capacity to consent, understand the study well, voluntarily volunteer to participate, and are able to consent to participation in the study in writing.
Key exclusion criteria
Individuals
1)currently undergoing drug treatment for any disease.
2)with a history or current history of serious illnesses such as malignancy, respiratory disease, liver, kidney, heart, lung, gastrointestinal, blood, endocrine, metabolic, drug dependence, alcohol dependence, mental disorders, etc.
3)with a history or current history of drug or food allergies.
4)with serious anemia.
5)who are pregnant, intend to become pregnant during the study period, or are breastfeeding.
6)Excessive smokers (average of more than 21 cigarettes/day).
7)who excessively take alcohol (expressed in an amount of alcohol: over 60g/day).
8)who cannot discontinue functional foods, foods for specified health uses, foods with nutrient function claims, supplements or foods containing lactic acid bacteria, bifidobacteria, oligosaccharides, lactoferrin, etc. during the study period.
9)who may require medication treatment due to hay fever or other allergic symptoms during the study period (excluding eye and nose drops).
10)Starting from the date of obtaining the consent document, women who had a blood draw of 400 mL or more within 16 weeks, men who had a blood draw of 400 mL or more within 12 weeks, or who had a blood draw of 200 mL or more within 4 weeks.
11)vaccinated within 4 weeks prior to the date of obtaining the consent document.
12)who work late night or shift work, physical labor, or have irregular lifestyle habits. Also, who may change their lifestyle during the examination period.
13)who are participating, or intend to participate, in research involving the ingestion of other foods or the use of pharmaceuticals, or the application of cosmetics and pharmaceuticals, or who have participated in other clinical research within 4 weeks prior to obtaining consent.
14)who are judged by the investigator to be unsuitable for the study based on the results of the subject's background, physical examination, interview, blood pressure and pulse rate, and clinical examination.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Toshitaka |
| Middle name | |
| Last name | Odamaki |
Organization
Morinaga Milk Industry Co., Ltd.
Division name
Innovative Research Institute, R&D Division
Zip code
252-8583
Address
5-1-83, Higashihara, Zama city, Kanagawa, Japan
TEL
046-252-3050
t-odamak@morinagamilk.co.jp
Public contact
Name of contact person
| 1st name | Ryoma |
| Middle name | |
| Last name | Shimizu |
Organization
TES Holdings Co., Ltd.
Division name
Administrative Department of Clinical Trials
Zip code
110-0015
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
TEL
+81-3-6801-8480
Homepage URL
r.shimizu@tes-h.co.jp
Sponsor or person
Institute
TES Holdings Co., Ltd.
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
Ueno-Asagao Clinic Ethical Review Committee
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
Tel
+81-3-6240-1162
jimukyoku@tes-h.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
| 2025 | Year | 01 | Month | 19 | 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 | 29 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 02 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 29 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 18 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 01 | Month | 17 | Day |
Last modified on
| 2024 | Year | 12 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064395
