UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059488 |
|---|---|
| Receipt number | R000068042 |
| Scientific Title | Safety Assessment of a Novel Lactic Acid Bacteria-Containing Food in Healthy Volunteers |
| Date of disclosure of the study information | 2025/10/27 |
| Last modified on | 2025/10/21 14:41:02 |
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Basic information
Public title
Safety Assessment of a Functional Food in Healthy Volunteers
Acronym
Safety Assessment of a Functional Food in Healthy Volunteers
Scientific Title
Safety Assessment of a Novel Lactic Acid Bacteria-Containing Food in Healthy Volunteers
Scientific Title:Acronym
Safety Assessment of a Novel Lactic Acid Bacteria-Containing Food in Healthy Volunteers
Region
| Japan |
Condition
Condition
Safety Assessment of a Functional Food in Healthy Volunteers
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This open-label exploratory study will be conducted in healthy men and women aged between 20 and 65 years who experience abdominal discomfort, such as bloating, associated with chronic constipation.
The study aims to evaluate the safety and exploratory efficacy of daily intake of the test food (a lactic acid bacteria-containing product) over a 4-week period.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Presence or absence of adverse events will be assessed based on
Number and incidence rate of adverse events (number of subjects with adverse events / number of subjects included in the safety analysis set)
Key secondary outcomes
Hematology and blood chemistry tests (hematological and biochemical parameters)
Urinalysis
Quality of life (QOL), stool characteristics, bowel movement frequency
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
Test product Duration of test food intake 4 weeks
Interventions/Control_2
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) Men and women aged 20 to 65 years at the time of obtaining consent to participate in the study.
2) Individuals suffering from chronic constipation and abdominal pain, bloating, or discomfort.
3) Individuals without chronic physical illnesses, including skin diseases.
4) Individuals who have received a full explanation of the purpose and content of the study, are competent to consent, fully understand
the content, and voluntarily volunteer to participate and provide written consent.
5) Individuals who are able to attend the study on the designated date and undergo the examination.
Key exclusion criteria
1) Those currently suffering from any illness and receiving drug treatment.
2) Those with a history or current illness of mental illness, sleep disorder, hypertension, diabetes, dyslipidemia, or other serious illnesses.
3) Those who have taken medication for the purpose of treating an illness within the past month (excluding those taking medication for headaches, menstrual pain, colds, etc.).
4) Those with a history or current serious illness involving the liver, kidneys, heart, lungs, blood, etc.
5) Those with a history or current serious coexisting illness involving the digestive system.
6) Subjects with drug or food allergies
7) Subjects currently or in the past month regularly consuming foods for specified health uses, foods with functional claims, or health
foods
8) Subjects who regularly consume fermented foods rich in lactic acid bacteria (e.g., cheese, yogurt, kimchi, and soybeans)
9) Subjects whose daily alcohol intake exceeds 30g of pure alcohol per day
10) Subjects who may change their lifestyle during the study period (e.g., long-term travel)
11) Pregnant, nursing, or potentially pregnant during the study period.
12) Currently participating in another human clinical trial, or within the last three months since participating in another human clinical
trial.
13) Other individuals who the investigator deems inappropriate for this study.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Takeo |
| Middle name | |
| Last name | Odaka |
Organization
Odaka Internal Medicine and Gastrointestinal Clinic
Division name
Clinic Director
Zip code
275-0028
Address
MF Building 2F, 1-12-3 Kana no Mori, Narashino City, Chiba Prefecture
TEL
047-477-5525
odk-tmrd@car.ocn.ne.jp
Public contact
Name of contact person
| 1st name | Ryuji |
| Middle name | |
| Last name | Takasaki |
Organization
BEYOND KAMPO Inc.
Division name
Director
Zip code
781-0087
Address
1-16 Minamikubo, Kochi City, Kochi Prefecture
TEL
090-4803-2888
Homepage URL
beyondkampo@gmail.com
Sponsor or person
Institute
BEYOND KAMPO Inc.
Institute
Department
Personal name
Funding Source
Organization
Flora Base 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
Hattori Gastroenterology Ethics Review Committee
Address
2-12-35 Shinmachi, Chuo Ward, Kumamoto City, Kumamoto Prefecture
Tel
096-325-2300
sakuraiko@jcom.zaq.ne.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 | 10 | Month | 27 | 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
| 2025 | Year | 10 | Month | 09 | Day |
Date of IRB
| 2025 | Year | 10 | Month | 21 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 24 | Day |
Last follow-up date
| 2025 | Year | 11 | 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
| 2025 | Year | 10 | Month | 21 | Day |
Last modified on
| 2025 | Year | 10 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068042
