UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058318 |
|---|---|
| Receipt number | R000066675 |
| Scientific Title | Effects of Dietary Fiber Intake Guidance on the Improvement of Chronic Constipation and Alterations in the Gut Microbiota |
| Date of disclosure of the study information | 2025/06/30 |
| Last modified on | 2025/06/30 14:38:41 |
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Basic information
Public title
Effects of Dietary Fiber Intake Guidance on the Improvement of Chronic Constipation and Alterations in the Gut Microbiota
Acronym
Effects of Dietary Fiber Intake Guidance on the Improvement of Chronic Constipation and Alterations in the Gut Microbiota
Scientific Title
Effects of Dietary Fiber Intake Guidance on the Improvement of Chronic Constipation and Alterations in the Gut Microbiota
Scientific Title:Acronym
Effects of Dietary Fiber Intake Guidance on the Improvement of Chronic Constipation and Alterations in the Gut Microbiota
Region
| Japan |
Condition
Condition
chronic constipation
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to establish a foundation for appropriate dietary guidance by providing dietary fiber intake instructions to elderly individuals with chronic functional constipation, and by evaluating the effects on constipation improvement and changes in the gut microbiota before and after the intervention.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the effects on constipation improvement and changes in the gut microbiota
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
by providing dietary fiber intake guidance
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 functional chronic constipation (as defined by the Rome IV criteria)
Patients with lifestyle-related diseases (such as hypertension, hyperlipidemia, or diabetes)
Patients with independent activities of daily living (ADL)
Key exclusion criteria
Patients who required adjustment of laxative medication within the past two months
Patients with obstructive disorders of the intestine
Patients with a history of ileus
Patients with inflammatory bowel disease (IBD)
Patients with a stoma
Patients who have taken antibiotics or probiotics within the past month
Patients taking proton pump inhibitors (PPIs)
Patients with cancer
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kyoko |
| Middle name | |
| Last name | Furusawa |
Organization
Yokohama-Minami Kyosai Hospital
Division name
Department of Gastroenterology
Zip code
236-0037
Address
1 Chome-21-1 Mutsuurahigashi, Kanazawa Ward, Yokohama, Kanagawa
TEL
045-782-2101
furusawa.kcch@gmail.com
Public contact
Name of contact person
| 1st name | Kyoko |
| Middle name | |
| Last name | Furusawa |
Organization
Yokohama-Minami Kyosai Hospital
Division name
Department of Gastroenterology
Zip code
236-0037
Address
1 Chome-21-1 Mutsuurahigashi, Kanazawa Ward, Yokohama, Kanagawa
TEL
045-782-2101
Homepage URL
furusawa.kcch@gmail.com
Sponsor or person
Institute
Yokohama-Minami Kyosai Hospital
Institute
Department
Personal name
Funding Source
Organization
Self found
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
Yokohama-Minami Kyosai Hospital IRB
Address
1 Chome-21-1 Mutsuurahigashi, Kanazawa Ward, Yokohama, Kanagawa
Tel
045-782-2101
furusawa.kcch@gmail.com
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
| 2025 | Year | 06 | Month | 30 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 06 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 12 | Month | 30 | Day |
Last follow-up date
| 2027 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 06 | Month | 30 | Day |
Last modified on
| 2025 | Year | 06 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066675
