UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054956 |
|---|---|
| Receipt number | R000062792 |
| Scientific Title | An open-label, randomized, controlled trial comparing the usefulness of support for abnormal bowel movements and conventional treatment using a cooking recipe website. |
| Date of disclosure of the study information | 2024/08/01 |
| Last modified on | 2025/08/20 22:08:32 |
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Basic information
Public title
An open-label, randomized, controlled trial comparing the usefulness of support for abnormal bowel movements and conventional treatment using a cooking recipe website.
Acronym
An open-label, randomized, controlled trial comparing the usefulness of support for abnormal bowel movements and conventional treatment using a cooking recipe website.
Scientific Title
An open-label, randomized, controlled trial comparing the usefulness of support for abnormal bowel movements and conventional treatment using a cooking recipe website.
Scientific Title:Acronym
An open-label, randomized, controlled trial comparing the usefulness of support for abnormal bowel movements and conventional treatment using a cooking recipe website.
Region
| Japan |
Condition
Condition
Chronic Stool Passage Abnormalities
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Chronic dysbiosis such as chronic constipation, chronic diarrhea, and irritable bowel syndrome are frequently treated in general internal medicine and gastroenterology outpatient clinics. The first step in the treatment of dysbiosis is to improve lifestyle and diet. Specifically, in the case of chronic constipation, dietary fiber intake (especially fiber from rice and legumes) is recommended, and in the case of chronic diarrhea and irritable bowel syndrome, a low-FODMAP diet is known to be effective. Although it is possible to provide abstract information on these dietary contents in daily medical care and nutritional guidance, it is difficult to grasp a concrete image. In this study, we will examine whether a cooking recipe website that provides patients with easy access to a variety of options can contribute to the improvement of abnormal bowel movements. We believe that this research will contribute to improving the satisfaction of both healthcare providers and patients by presenting a wide variety of easy-to-use options for interventions related to dietary content, which is of great interest to the general public.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Superiority of improvement in bowel movement-related symptoms over the conventional treatment group after using a cooking recipe website
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Use of cooking recipe sites
Interventions/Control_2
conventional therapy
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 chronic abnormal bowel movements who are currently receiving treatment at Keio University Hospital.
Patients over 18 years old.
Key exclusion criteria
Patients who are unable to prepare and serve food by themselves or by family members or caregivers.
Patients who are deemed inappropriate for inclusion in the study by their physicians.
Target sample size
80
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
16
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
160
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
Institute
Department
Personal name
Funding Source
Organization
donation
Organization
Division
Category of Funding Organization
Other
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-ft_pt@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
| 2024 | 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
| 2024 | Year | 07 | Month | 12 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 30 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 07 | Month | 12 | Day |
Last modified on
| 2025 | Year | 08 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062792
