UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023861 |
|---|---|
| Receipt number | R000027490 |
| Scientific Title | The clinical evaluation about the bowel movement improvement effected by the dietary fiber-containing jelly drink intake. |
| Date of disclosure of the study information | 2016/09/01 |
| Last modified on | 2018/05/24 22:16:52 |
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Basic information
Public title
The clinical evaluation about the bowel movement improvement effected by the dietary fiber-containing jelly drink intake.
Acronym
The clinical evaluation of the bowel movement improvement effected by the dietary fiber-containing jelly drink intake.
Scientific Title
The clinical evaluation about the bowel movement improvement effected by the dietary fiber-containing jelly drink intake.
Scientific Title:Acronym
The clinical evaluation of the bowel movement improvement effected by the dietary fiber-containing jelly drink intake.
Region
| Japan |
Condition
Condition
Constipation
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess bowel movement improvement effect of dietary fiber-containing jelly
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Number of defecation per day (Defecation rate)
Key secondary outcomes
Defecation frequency, fecal property, amount of feces, number of days and frequency of laxative use
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
One pouch of dietary fiber-containing jelly is to be taken each day on 14 consecutive days after 14 days of non-intake period.
Interventions/Control_2
A total of 100 mL water is to be taken each day on 14 consecutive days after 14 days of non-intake period.
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patient considered to have functional constipation
2) Patient aware of what and how much he/she takes
3) Patient who has consumed at least 80% of the meal offered before the start of the study
4) Patient who is in a hospital or in a healthcare facility
Key exclusion criteria
1) Patient considered to have organic constipation
2) Patient who has metabolic disorder
3) Patient treated with opium alkaloid, anticholinergic drug, anesthetic drug, hypotensive drug having ganglionic blocking action, or antidepressant drug
4) Patient who has neuropathy
5) Patient who has markedly painful hemorrhoid, anal fissure, or anal fistula, etc.
6) Patient who has artificial anus
7) Patient who developed aspiration pneumonia within one month
8) Patient who takes dietary fiber contained in fluid diet or other food products by 15 g/day or more in total
9) Patient who was determined to be ineligible for the assessment by a doctor
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Sadao Yoshida |
Organization
Okinawa Medical Hospital
Division name
internal medicine
Zip code
Address
Nishihara2310, Sashiki Tsuhako, Nanjyo-shi, Okinawa, 901-1414, Japan
TEL
098-947-3555
info@rinsyou-siken.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sadao Yoshida |
Organization
Okinawa Medical Hospital
Division name
internal medicine
Zip code
Address
Nishihara2310, Sashiki Tsuhako, Nanjyo-shi, Okinawa, 901-1414, Japan
TEL
098-947-3555
Homepage URL
info@rinsyou-siken.jp
Sponsor or person
Institute
Okinawa Medical Hospital
Institute
Department
Personal name
Funding Source
Organization
NUTRI Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2016 | Year | 09 | Month | 01 | 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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 08 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2017 | 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
| 2016 | Year | 08 | Month | 31 | Day |
Last modified on
| 2018 | Year | 05 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027490
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
