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 2017/11/06 13:22:31

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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

Email

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


Email

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


Email



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

Date of protocol fixation

2016 Year 10 Month 06 Day

Date of IRB


Anticipated trial start date

2016 Year 10 Month 06 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Nothing


Management information

Registered date

2016 Year 10 Month 07 Day

Last modified on

2017 Year 11 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028014


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name