UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051774 |
|---|---|
| Receipt number | R000059087 |
| Scientific Title | Prospective cohort study of chronic diarrhea treatment |
| Date of disclosure of the study information | 2023/08/01 |
| Last modified on | 2024/07/31 10:24:00 |
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Basic information
Public title
Prospective cohort study of chronic diarrhea treatment
Acronym
Prospective cohort study of chronic diarrhea treatment
Scientific Title
Prospective cohort study of chronic diarrhea treatment
Scientific Title:Acronym
Prospective cohort study of chronic diarrhea treatment
Region
| Japan |
Condition
Condition
chronic diarrhea
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Chronic diarrhea is a disease encountered in all medical institutions and departments. The causes of diarrhea include drug-induced, diet-induced, cholestatic, infectious, symptomatic, and organic diarrhea, and diarrhea of unknown cause that does not fit into any of these categories is diagnosed as functional diarrhea or diarrhea-type irritable bowel syndrome. Many patients with diarrhea of unknown cause present to the gastroenterology department, but it is difficult to evaluate the cause of these symptoms with a simple medical interview alone. In addition, diarrheal symptoms are considered to be related to the quality of daily life, but it is difficult to comprehensively quantify the patient's complaints. In the case of drug- or diet-induced diarrhea, discontinuation of the relevant drug or food is considered effective. In the case of bile acidity, bile adsorption therapy is the first choice; in the case of symptomatic disease, treatment of the present illness is the priority. To comprehensively check the causes of diarrhea and to identify problems in quality of life and daily living due to symptoms, an outpatient clinic using a questionnaire method may be useful, but there is no established method. Therefore, the background and scientific rationale for this study is that there is a need to conduct a comprehensive search of disease background based on past findings and quantitative evaluation of QOL, severity of illness, drugs used, and dietary therapy.
Therefore, we believe that we can present a model that shows the maturation of chronic diarrhea treatment by thoroughly identifying the background of patients with diarrhea symptoms, evaluating current and past symptoms and quality of life, and comprehensively assessing the effectiveness of current treatments. We believe that we can present a model that shows the maturation of chronic diarrhea treatment.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percentage reduction in daily stool frequency with diarrhea medications
Key secondary outcomes
Correlation of disease background and symptoms with efficacy of diarrhea medications (lower gastrointestinal endoscopy findings, abdominal X-ray findings, abdominal CT findings, enterography findings, blood test findings, rectal manometry findings, colon function test findings, blood pressure, abdominal and mental symptoms at presentation (GI symptoms questionnaire, HADS questionnaire, WPAI:GH questionnaire, Bristol stool Scale)). Association of symptoms with quality of life, labor productivity, anxiety and depression in diarrhea. Safety of diarrhea medications.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with diarrhea symptoms defined in the Guidelines for the Diagnosis and Treatment of Bowel Movements (Chronic Constipation Syndrome/Chronic Diarrhea Syndrome) 2023: "Soft and watery stools with increased frequency of defecation". Outpatients attending Keio University Hospital. Patients who have given consent for this study. Patients must be 18 years of age or older.
Key exclusion criteria
Patients with organic disease as a possible cause of diarrheal symptoms.
Other patients who are deemed inappropriate for inclusion in the study by the investigators.
Target sample size
800
Research contact person
Name of lead principal investigator
| 1st name | Hideki |
| Middle name | |
| Last name | Mori |
Organization
Keio University School of Medicine
Division name
Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code
160
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
0333531211
koyamaru2002@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Hideki |
| Middle name | |
| Last name | Mori |
Organization
Keio University School of Medicine
Division name
Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code
1608582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
0333531211
Homepage URL
koyamaru2002@yahoo.co.jp
Sponsor or person
Institute
Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan
Institute
Department
Personal name
Hideki Mori
Funding Source
Organization
Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University School of Medicine Ethics Committee
Address
35 Shinanomachi, SHinjuku-ku, Tokyo
Tel
0333531211
med-rinri-jimu@adst.keio.ac.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
| 2023 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-bin/ctr/ctr_up_rec_f5.cgi
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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 06 | Month | 06 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 31 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
During the study period, research subjects will visit the hospital as indicated in 6. Methods of the study, and necessary observations will be made at each scheduled visit. Observations and examinations will be conducted and collected as follows
Information on disease background, treatment details, and symptoms will be collected using medical records and questionnaires.
a. Disease background
Age, gender, height, weight, dietary habits, preferences (degree of smoking and drinking habits), blood test findings, medical history, medication history, and clinical course up to the visit.
b. Details of treatment
Details of medical treatment, duration of medication, and medication status. Effectiveness of treatment.
c. Disease severity
Upper and lower gastrointestinal endoscopy findings, abdominal X-ray findings, abdominal CT findings, enterography findings, blood test findings, rectal pressure measurement findings, colon function test findings, blood pressure, abdominal and mental symptoms at presentation (GI symptoms questionnaire, HADS questionnaire, WPAI:GH questionnaire, Bristol stool scale assessment), blood test data, endoscopic findings, and imaging findings. The results of blood test data, endoscopic findings, and imaging findings will be used for the examination results of the usual medical examinations.
Management information
Registered date
| 2023 | Year | 08 | Month | 01 | Day |
Last modified on
| 2024 | Year | 07 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059087
