UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048219 |
|---|---|
| Receipt number | R000054949 |
| Scientific Title | A study for validating the effective behavioral change approaches in those having abdominal symptoms |
| Date of disclosure of the study information | 2022/07/01 |
| Last modified on | 2022/12/20 08:45:42 |
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Basic information
Public title
A study for validating the effective behavioral change approaches in those having abdominal symptoms
Acronym
A study for validating the effective behavioral change approaches in those having abdominal symptoms
Scientific Title
A study for validating the effective behavioral change approaches in those having abdominal symptoms
Scientific Title:Acronym
A study for validating the effective behavioral change approaches in those having abdominal symptoms
Region
| Japan |
Condition
Condition
Abdominal pain that is relieved by defecation
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To validate the effective behavioral change approaches and duration for receiving medical treatments in those having abdominal symptoms
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Validation of the effective behavioral change approaches for medical treatments
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
For the intervention group, the subjects will receive the survey and useful information for the abdominal symptoms during the experiment biweekly (total 3 times)
Interventions/Control_2
For the control group, the subject will receive the simple survey during the experiment biweekly (total 3 times)
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
| 50 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Subjects whose age is between 20 and 49 years old
(2) Subjects who are currently having abdominal symptoms
(3) Subjects who do not have infectious diseases of the respiratory tract
(4) Subjects who can answer the online survey using their own digital device
(5) Subjects who agree to participate in the surveys relating to their own health as well as the follow-up survey (total 4 surveys)
(6) Subjects who agree to learn about their unknown health status including being judged by doctors
(7) Subjects who agree to participate in the study
Key exclusion criteria
(1) Subjects who had irritable bowel syndrome
(2) Subjects who are currently seeing a doctor due to the abdominal symptoms
Target sample size
130
Research contact person
Name of lead principal investigator
| 1st name | Ken |
| Middle name | |
| Last name | Kasahara |
Organization
Chitose Laboratory Corp.
Division name
Executive Officer, Managing Director/Chief Technology Officer
Zip code
213-0012
Address
KSP East 511, 3-2-1 Sakado Takatsu-ku, Kawasaki, Kanagawa
TEL
044-813-3380
Info_healthcare@chitose-bio.com
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Kawaharada |
Organization
Chitose Laboratory Corp.
Division name
Tech & Biz Development Div.
Zip code
213-0012
Address
KSP East 511, 3-2-1 Sakado Takatsu-ku, Kawasaki, Kanagawa
TEL
044-813-3380
Homepage URL
Info_healthcare@chitose-bio.com
Sponsor or person
Institute
Chitose Laboratory Corp.
Institute
Department
Personal name
Funding Source
Organization
Kirin Holdings Company, Limited
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kirin Holdings Company, Limited
Name of secondary funder(s)
Fujisawa Shounandai Hospital
IRB Contact (For public release)
Organization
Fujisawa Shounandai Hospital
Address
Takakura 2345, Fujisawa, Kanagawa
Tel
0466-44-1451
t_ohata@fj-shounandai.or.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
| 2022 | Year | 07 | 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
123
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
Completed
Date of protocol fixation
| 2022 | Year | 06 | Month | 09 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 09 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 07 | Month | 01 | Day |
Last modified on
| 2022 | Year | 12 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054949
