UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051102 |
|---|---|
| Receipt number | R000058277 |
| Scientific Title | The Impact of High-Fiber Liquid Diets on Bowel Movements and Bowel Management in Individuals with Chronic Constipation |
| Date of disclosure of the study information | 2023/05/19 |
| Last modified on | 2023/09/26 14:11:55 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The Impact of High-Fiber Liquid Diets on Bowel Movements and Bowel Management in Individuals with Chronic Constipation
Acronym
The Impact of High-Fiber Liquid Diets on Patients with Chronic Constipation
Scientific Title
The Impact of High-Fiber Liquid Diets on Bowel Movements and Bowel Management in Individuals with Chronic Constipation
Scientific Title:Acronym
The Impact of High-Fiber Liquid Diets on Patients with Chronic Constipation
Region
| Japan |
Condition
Condition
Chronic constipation
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the effects of ISOCAL Fibecare with an existing enteral nutrition on chronic constipation in bedridden patients with chronic constipation using enteral nutrition and admitted to a chronic care ward for eight weeks.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The change in the number of normal bowel movements from the baseline (the two weeks before the intervention) to 6-8 weeks (2 weeks) after the intervention.
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
| Food |
Interventions/Control_1
Using ISOCAL Fibecare for 8 weeks
Interventions/Control_2
Using Meibalance 1.5 for 8 weeks
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Long-term hospitalized patients who have been bedridden for more than 6 months
2.Patients who have difficulty defecating on their own
3.Patients over 20 years of age, regardless of gender
4.Patients who have been on enteral feeding with Maibalance 1.5 for at least 4 weeks prior to obtaining consent
5.Patients diagnosed with functional constipation according to Rome IV diagnostic criteria for chronic constipation
6.Patients with written consent
Key exclusion criteria
1.Patients with or suspected of having organic constipation, functional ileus, or inguinal hernia
2.Patients deemed inappropriate as study subjects by the principal investigator
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kentaro |
| Middle name | |
| Last name | Nakao |
Organization
IMS Yokohama Higashi-Totsuka Comprehensive Rehabilitation Hospital
Division name
Director
Zip code
244-0805
Address
690-2 Kawakami-town, Totsuka-ku, Yokohama-city, Kanagawa-ken, Japan.
TEL
045-822-4151
sth-eiyouka@ims.gr.jp
Public contact
Name of contact person
| 1st name | Kurumi |
| Middle name | |
| Last name | Takahashi |
Organization
IMS Yokohama Higashi-Totsuka Comprehensive Rehabilitation Hospital
Division name
Dietetics department
Zip code
244-0805
Address
690-2 Kawakami-town, Totsuka-ku, Yokohama-city, Kanagawa-ken, Japan.
TEL
045-822-4151
Homepage URL
sth-eiyouka@ims.gr.jp
Sponsor or person
Institute
IMS Yokohama Higashi-Totsuka Comprehensive Rehabilitation Hospital
Institute
Department
Personal name
Funding Source
Organization
IMS Yokohama Higashi-Totsuka Comprehensive Rehabilitation Hospital
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
Ethics Committee of IMS Yokohama Higashi-Totsuka Comprehensive Rehabilitation Hospital
Address
690-2 Kawakami-town, Totsuka-ku, Yokohama-city, Kanagawa-ken, Japan.
Tel
045-822-4151
sth-eiyouka@ims.gr.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 | 05 | Month | 19 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 04 | Month | 12 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 18 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 22 | Day |
Last follow-up date
| 2023 | 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
| 2023 | Year | 05 | Month | 19 | Day |
Last modified on
| 2023 | Year | 09 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058277
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
