UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058028 |
|---|---|
| Receipt number | R000066326 |
| Scientific Title | Evaluation of the efficacy and acceptability of a test food in healthy subjects with diarrhea-predominant irritable bowel syndrome-like symptoms |
| Date of disclosure of the study information | 2025/06/07 |
| Last modified on | 2025/05/30 15:57:23 |
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Basic information
Public title
Evaluation of the efficacy and acceptability of a test food in healthy subjects with diarrhea-predominant irritable bowel syndrome-like symptoms
Acronym
Evaluation of the efficacy and acceptability of a test food in healthy subjects with diarrhea-predominant irritable bowel syndrome-like symptoms
Scientific Title
Evaluation of the efficacy and acceptability of a test food in healthy subjects with diarrhea-predominant irritable bowel syndrome-like symptoms
Scientific Title:Acronym
Evaluation of the efficacy and acceptability of a test food in healthy subjects with diarrhea-predominant irritable bowel syndrome-like symptoms
Region
| Japan |
Condition
Condition
Healthy volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate the symptom-relieving effects and acceptability of the test food in healthy individuals with diarrhea-predominant irritable bowel syndrome-like symptoms.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Subject's global assessment
Key secondary outcomes
Stool consistency (Bristol Stool Form Scale), Abdominal symptoms, Test food intake record, Abdominal symptoms questionnaire
GSRS
Bowel movement frequency
WPAI
SF-8
POMS2 short version
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Oral; 12 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) Japanese men and women aged 20 to 65 at the time of obtaining consent
2) Individuals suffering from diarrhea accompanied by abdominal pain and discomfort
3) Individuals who can complete an online-based lifestyle record diary during the 18-week study period
4) Individuals who are not undergoing treatment for any illness or taking any medication
Key exclusion criteria
1) Individuals currently undergoing any form of medication or outpatient treatment
2) Individuals currently receiving medical treatment at a medical institution for a digestive disease that may affect intestinal function, or those with a history of gastrointestinal surgery (excluding appendectomy)
3) Individuals with a history of diseases such as ulcerative colitis that may significantly affect bowel movements
4) Individuals who have been diagnosed with irritable bowel syndrome as the cause of diarrhea accompanied by abdominal pain and discomfort
5) Individuals who regularly use over-the-counter medicines or quasi-drugs for the prevention or treatment of diarrhea with abdominal pain or discomfort
6) Individuals currently receiving outpatient treatment specifically for diarrhea accompanied by abdominal pain or discomfort
7) Individuals who regularly use nonsteroidal anti-inflammatory drugs (NSAIDs), steroids, or antibiotics
8) Individuals with severe diarrhea accompanied by abdominal pain and discomfort, who are deemed by the principal investigator to require medical treatment
9) Individuals with a history of drug or food allergies (e.g., milk)
10) Individuals who are pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study period
11) Individuals currently receiving treatment for mental disorders (e.g., depression) or sleep disorders, or those with a history of psychiatric treatment
12) Individuals with extremely irregular lifestyle habits, such as inconsistent eating and sleeping patterns
13) Individuals currently participating in another clinical trial or who have participated in one within the past month
14) Individuals who may have difficulty complying with various questionnaires or maintaining study-related records
15) Any other individuals deemed unsuitable for the study by the principal investigator
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Tadashi |
| Middle name | |
| Last name | Watanabe |
Organization
Watanabe Hospital
Division name
Chairperson
Zip code
144-0043
Address
1-5-16, Haneda, Ota-ku, Tokyo, Japan
TEL
03-3741-0223
wnb.cto@gmail.com
Public contact
Name of contact person
| 1st name | Tatsuo |
| Middle name | |
| Last name | Uetake |
Organization
CXwellness, Inc.
Division name
Representative Directo
Zip code
173-0004
Address
2-63-9-401 Itabashi, Itabashi-ku, Tokyo JAPAN
TEL
03-6915-5507
Homepage URL
uetake@cx-wellness.com
Sponsor or person
Institute
Yakult Honsha Co., Ltd.
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
Ethics Review Committee of Watanabe Hospital
Address
1-5-16, Haneda, Ota-ku, Tokyo, JAPAN
Tel
03-3741-0223
wnb@cto-net.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 | 06 | Month | 07 | 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 | 05 | Month | 19 | Day |
Date of IRB
| 2025 | Year | 05 | Month | 28 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 07 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | 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 | 05 | Month | 30 | Day |
Last modified on
| 2025 | Year | 05 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066326
