UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058418 |
|---|---|
| Receipt number | R000066779 |
| Scientific Title | Verification study on the effects of a gut health support program on constipation-related indicators |
| Date of disclosure of the study information | 2025/07/10 |
| Last modified on | 2025/07/10 10:32:47 |
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Basic information
Public title
Verification study on the effects of a gut health support program on constipation-related indicators
Acronym
Verification study on the effects of a gut health support program on constipation-related indicators
Scientific Title
Verification study on the effects of a gut health support program on constipation-related indicators
Scientific Title:Acronym
Verification study on the effects of a gut health support program on constipation-related indicators
Region
| Japan |
Condition
Condition
Healthy Adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate whether the continuous use of the gut health support program "Gut Note" app can alleviate issues caused by constipation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Gut Sounds and Bowel Movement Indicators
Key secondary outcomes
1)World Health Organization Quality of Life 26
2)Patient Assessment of Constipation Quality of Life
3)Work Productivity and Activity Impairment Questionnaire: Constipation
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 years or older at the time of obtaining consent for participation in the study and under 65 years old at the time of study completion.
2)Individuals who experience symptoms of constipation.
3)Individuals with a bowel movement frequency of 2-5 times per week.
4)iPhone users who are capable of using a smartphone without any issues.
5)Individuals who can receive explanations and undergo examinations in a remote environment.
6)Individuals who have fully understood the purpose and content of this study and have provided consent via both the web and in writing.
Key exclusion criteria
1)Individuals undergoing any form of medical treatment at the time of trial participation.
2)Pregnant women (including those who may be pregnant) or women who are breastfeeding.
3)Individuals currently enrolled in another clinical trial as a subject, or those who have participated in another trial within four weeks after its completion.
4)Individuals who meet any of the following criteria:
a) Those with diseases of the heart, liver, or kidneys (including cases involving complications from other diseases).
b) Those with a history of cardiovascular diseases.
c) Those diagnosed with diabetes.
5)Heavy drinkers (average pure alcohol intake of 60 g/day or more).
6)Individuals with highly irregular dietary habits.
7)Individuals engaged in shift work or night shifts, or whose lifestyle is irregular, including those who expect such changes in the near future.
8)Individuals whose lifestyle habits are likely to change during the study period.
9)Individuals who have suffered from or are currently suffering from serious intestinal diseases (such as ulcerative colitis, Crohn's disease, colorectal cancer, appendicitis, etc.).
10)Individuals using a cardiac pacemaker.
11)Any other individuals judged as unsuitable for the trial by the principal investigator.
Target sample size
63
Research contact person
Name of lead principal investigator
| 1st name | Soma |
| Middle name | |
| Last name | Ode |
Organization
Macromill, Inc.
Division name
Clinical Trial Unit, 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 | Ayumi |
| Middle name | |
| Last name | Sugioka |
Organization
Macromill, Inc.
Division name
Clinical Trial Unit, 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
sugioka@macromill.com
Sponsor or person
Institute
Macromill, Inc.
Institute
Department
Personal name
Funding Source
Organization
chonote 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
Institutional review board of Tsukiji Futaba Clinic
Address
Tsukiji 1-9-9, Chuou-ku, Tokyo, Japan, 104-0045
Tel
03-6226-5812
tohru@hikobae.net
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 | 07 | Month | 10 | 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 | 07 | Month | 09 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 09 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 09 | 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
Cohort Study
Management information
Registered date
| 2025 | Year | 07 | Month | 10 | Day |
Last modified on
| 2025 | Year | 07 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066779
