UMIN-ICDS Clinical Trial

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

chronic diarrhea

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO

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

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.

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

Email

koyamaru2002@yahoo.co.jp

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

Email

koyamaru2002@yahoo.co.jp

Institute

Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan

Institute

Department

Personal name

Hideki Mori

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

Co-sponsor

Name of secondary funder(s)

Organization

Keio University School of Medicine Ethics Committee

Address

35 Shinanomachi, SHinjuku-ku, Tokyo

Tel

+819098610392

Email

ocr@crea.hosp.keio.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2023

Year

08

Month

01

Day

URL releasing protocol

https://center6.umin.ac.jp/cgi-bin/ctr/ctr_up_rec_f5.cgi

Publication of results

Unpublished

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

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 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.

Registered date

2023

Year

08

Month

01

Day

Last modified on

2023

Year

08

Month

01

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059087