UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059229 |
|---|---|
| Receipt number | R000067748 |
| Scientific Title | Effects of Continuous Intake of the Test Food on Bowel Regulation in Individuals Prone to Diarrhea |
| Date of disclosure of the study information | 2026/04/01 |
| Last modified on | 2025/10/23 11:39:47 |
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Basic information
Public title
Effects of Continuous Intake of the Test Food on Bowel Regulation in Individuals Prone to Diarrhea
Acronym
Effects of Continuous Intake of the Test Food on Bowel Regulation in Individuals Prone to Diarrhea
Scientific Title
Effects of Continuous Intake of the Test Food on Bowel Regulation in Individuals Prone to Diarrhea
Scientific Title:Acronym
Effects of Continuous Intake of the Test Food on Bowel Regulation in Individuals Prone to Diarrhea
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study on the Effects of Four-Week Continuous Intake of the Test Food on Gastrointestinal and Associated Symptoms in Healthy Individuals with Diarrhea
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
(1) Bowel Movement Questionnaire
Key secondary outcomes
(1) Skin, Allergic Symptoms, and Fatigue Questionnaire (VAS)
(2) Stress Questionnaire (POMS-2 Adult Short Form)
(3) Gut Microbiota Analysis
(4) Short-Chain Fatty Acids
(5) Fecal Metabolites, etc.
(6) Skin Viscoelasticity
(7) Trans Epidermal Water Loss
(8) Daily Log (Frequency/Severity of Health Concerns/Problems)
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
3
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
4-week intake of test food-1
Interventions/Control_2
4-week intake of test food-2
Interventions/Control_3
4-week intake of placebo foods
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) Male and female participants aged 20 years or older and younger than 65 years at the time of informed consent.
(2) Individuals with a bowel movement frequency of 7 times or more per week and soft stool consistency (Bristol Stool Form Scale type 4 to less than 7).
(3) Individuals who have received sufficient explanation regarding the purpose and content of the study, have the capacity to consent, fully understand the information provided, voluntarily agree to participate, and provide their own consent via electronic informed consent (eConsent).
Key exclusion criteria
(1) Individuals using bowel-regulating drugs, such as laxatives or antidiarrheals, including over-the-counter products.
(2) Those under treatment for chronic diseases such as diabetes, dyslipidemia, or hypertension.
(3) Those with malignant tumors; cerebrovascular, cardiac, hepatic, renal, hematologic, or endocrine disease; gastric or duodenal ulcer under treatment; or a severe medical history.
(4) History of major gastrointestinal surgery, including gastrectomy, anastomosis, or intestinal resection, except for appendectomy only.
(5) Dermatological conditions such as atopic dermatitis, allergy, eczema, or hypersensitivity under treatment.
(6) Cosmetic procedures at the evaluation site within the past 12 weeks, such as collagen, hyaluronic acid, botulinum toxin, or laser, or those unable to refrain during the study.
(7) Excessive tanning or inability to avoid intentional sun exposure.
(8) Allergy to the test food.
(9) Habitual use of health foods, foods with functional claims, probiotics such as yogurt or lactic drinks, or supplements, and unable to stop during the study.
(10) Heavy smokers, defined as more than 20 cigarettes per day.
(11) Regular alcohol consumers, defined as 60 grams or more of pure alcohol per day, approximately sake three servings, beer 1,500 mL, shochu two servings, or wine 600 mL, on six or more days per week.
(12) Extremely irregular sleep or diet, such as shift or night workers.
(13) Likely to experience major lifestyle, diet, or exercise changes during the study.
(14) Women who are lactating, pregnant, possibly pregnant, or planning pregnancy.
(15) Currently in another clinical trial, within the past four weeks, or planning to join during this study.
(16) Deemed ineligible by the principal investigator or sub-investigator.
(17) Deemed unsuitable by the sponsor.
Target sample size
195
Research contact person
Name of lead principal investigator
| 1st name | Soma |
| Middle name | |
| Last name | Ode |
Organization
Macromill, Inc.
Division name
Clinical Trial Department, Life Science Division
Zip code
108-0075
Address
Shinagawa East One Tower 11F, 2-16-1 Konan, Minato-ku, Tokyo, Japan
TEL
03-6716-0700
ohde@macromill.com
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Mori |
Organization
Macromill, Inc.
Division name
Clinical Trial Department, Life Science Division
Zip code
108-0075
Address
Shinagawa East One Tower 11F, 2-16-1 Konan, Minato-ku, Tokyo, Japan
TEL
03-6716-0700
Homepage URL
yuk_mori@macromill.com
Sponsor or person
Institute
Macromill, Inc.
Institute
Department
Personal name
Funding Source
Organization
MP Gokyo Food & Chemical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
PreMedica Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee of Kobuna Orthopedics Clinic
Address
311-2 Joto-machi, Maebashi-shi, Gumma
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
| 2026 | Year | 04 | Month | 01 | 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 | 09 | Month | 29 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 29 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 30 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 08 | 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 | 09 | Month | 29 | Day |
Last modified on
| 2025 | Year | 10 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067748
