UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024334 |
|---|---|
| Receipt number | R000028014 |
| Scientific Title | Research for Actual Situation of Constipation in the Japanese. -Examination of food choice, the coping method and satisfaction in patients with constipation by internet survey.- |
| Date of disclosure of the study information | 2017/11/06 |
| Last modified on | 2024/11/25 19:40:54 |
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Basic information
Public title
Research for Actual Situation of Constipation in the Japanese.
-Examination of food choice, the coping method and satisfaction in patients with constipation by internet survey.-
Acronym
Reaction-J
Scientific Title
Research for Actual Situation of Constipation in the Japanese.
-Examination of food choice, the coping method and satisfaction in patients with constipation by internet survey.-
Scientific Title:Acronym
Reaction-J
Region
| Japan |
Condition
Condition
Constipation
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Aim:We evaluate and performed questionnaire to patients who complain of constipation using the internet. Then divide the group to meet the IBS-C, FC and control group for each using the ROME criteria. At this survey we collect the contents of the food choices, lifestyle habit, fork remedy, selection of laxative. From those point considered to be a very useful research on assessment of treatment strategies for constipation disease.
Basic objectives2
Others
Basic objectives -Others
Whether the person of constipation disease and two of the above diseases are any such action is considered to be a relief. Further evaluation of the purchase method and the price of constipation drug in question is positioned as economic evaluation for the medicine in the direction of constipation.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of primary outcomes
Diagnose using Rome Criteria for irritable bowel syndrome with constipation (IBS-C) and functional constipation (FC). Use the Bristol stool scale for states of constipation.
IBS-SI: Determines the severity of irritable bowel syndrome.
IBS-QOL: a) Dysphoria; b) Interference with activity; c) Body image; d) Health worry; e) Food avoidance; f) Social reaction; g) Sexual Problems; h) Relationships
SF-8: Evaluates physical functioning, role functioning (physical), bodily pains, general health, vitality, social functioning, role functioning (psychological), and mental health.
HADS: Evaluate psychiatric symptoms of patients with physical illness using seven items from both depression and anxiety. Evaluate the quality of sleep using PSQI.
FMPS: Evaluate on perfectionism. Evaluate the six indices of concern over mistakes (CM), personal standards (PS), parental expectations (PE), parental criticism (PC), doubts about action (DA), and organization (OR).
JHPI: Correlation between lifestyle and lifestyle-related diseases (obesity, impaired glucose tolerance, high blood pressure, hyperlipidemia, low HDL cholesterol, hyperuricemia, and liver dysfunction) was evident in questionnaires that were answered in particular medical examinations in Japan. Investigate symptoms to evaluate the correlation between basic lifestyle information and medications being taken to treat concomitant symptoms of people suffering from IBS-C, FC, or constipation. FODMAP questionnaire: Use high and low FODMAP diet presented by Stanford University to investigate food choices of people suffering from IBS-C, FC, or constipation.
Questions related to eating and exercise habits will be scientifically evaluated to see whether they correlate with constipations or abdominal symptoms that are common in our daily lives.
Key secondary outcomes
Secondary Outcomes
Behaviors of people suffering from IBS-C, FC, and constipation will be revealed. Further evaluation of purchase methods and prices of constipation medications in the questionnaire will be an economic evaluation for constipation medication.
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
| 69 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Subjects in this study Presence or absence of a medical institution examination and oral dosing in humans to realize the constipation does not matter. If you obtained in the intention on the net the consent of the research participation voluntary. Men and women from 20 years of age to 69 years of age.
Key exclusion criteria
Exclusion criteria in the preliminary investigation stage.
Been a laparotomy surgery of the abdomen, except for appendicitis.
If there is a disease of the bowel, such as inflammatory bowel disease, ulcerative colitis, Crohn's disease. Those who have been diagnosed with cancer of the digestive tract. Women who are pregnant.
Target sample size
3000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kunio Kasugai |
Organization
Aichi Medical Univercity
Department of Internal Mecicine
Division name
Gastroenterology
Zip code
Address
1-1 Yazako karimata Nagakute Aichi
TEL
0561-61-3311
kuku3487@aichi-med-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sayuri Yamamoto |
Organization
Aichi Medical Univercity Department of Internal Mecicine
Division name
Gastroenterology
Zip code
Address
1-1 Yazako karimata Nagakute Aichi
TEL
0561-62-3311
Homepage URL
yuri3337@aichi-med-u.ac.jp
Sponsor or person
Institute
Aichi Medical Univercity Department of Internal Mecicine
Gastroenterology
Institute
Department
Personal name
Funding Source
Organization
EA phama 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
Address
Tel
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
| 2017 | Year | 11 | Month | 06 | 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
Completed
Date of protocol fixation
| 2016 | Year | 10 | Month | 06 | Day |
Date of IRB
| 2016 | Year | 10 | Month | 04 | Day |
Anticipated trial start date
| 2016 | Year | 10 | Month | 06 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 12 | Month | 31 | Day |
Other
Other related information
The following paper was published based on the data analysis.
https://pubmed.ncbi.nlm.nih.gov/31708504/ Internet survey of the actual situation of constipation in Japanese general population REACTION-J:Research for Actual Situation of Constipation in the Japanese
https://bpsmedicine.biomedcentral.com/articles/10.1186/s13030-022-00237-2 Background factors involved in the epidemiology of functional constipation in the Japanese population: a cross-sectional study
https://www.jnmjournal.org/journal/view.html?doi=10.5056/jnm20135 The following paper was published based on the data analysis.
Management information
Registered date
| 2016 | Year | 10 | Month | 07 | Day |
Last modified on
| 2024 | Year | 11 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028014
