UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000034818 |
|---|---|
| Receipt number | R000039706 |
| Scientific Title | Analysis of the efficacy of brown rice-specific gamma-oryzanol for children with constipation |
| Date of disclosure of the study information | 2018/11/08 |
| Last modified on | 2020/11/09 08:07:13 |
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Basic information
Public title
Analysis of the efficacy of brown rice-specific gamma-oryzanol for children with constipation
Acronym
Analysis of the efficacy of brown rice-specific gamma-oryzanol for children with constipation
Scientific Title
Analysis of the efficacy of brown rice-specific gamma-oryzanol for children with constipation
Scientific Title:Acronym
Analysis of the efficacy of brown rice-specific gamma-oryzanol for children with constipation
Region
| Japan |
Condition
Condition
Constipation
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy of gamma-oryzanol for children with constipation
Gamma-oryzanol is a brewed non-alcoholic beverage derived from brown rice
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Intestinal microbiota at 1 month from randomization (gamma-oryzanol group or control group)
Key secondary outcomes
Short chain fatty acids (Acetic acid, butyric acid, propionic acid, valeric acid) in serum
Symptoms of constipation
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Patient ingests brown rice-specific gamma-oryzanol for 1 month
Interventions/Control_2
Patient does not ingest brown rice-specific gamma-oryzanol for 1 month
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
| 1 | years-old | <= |
Age-upper limit
| 18 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who meet the criteria for chronic functional constipation disease
Key exclusion criteria
Decision of ineligibility by a physician
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Noriyuki |
| Middle name | |
| Last name | Yanagida |
Organization
National Hospital Organization Sagamihara National Hospital
Division name
Department of Pediatrics
Zip code
252-0392
Address
18-1, Sakuradai, Minamiku, Sagamihara City, Kanagawa, Japan, 252-0392
TEL
042-742-8311
sagamiharahospital@gmail.com
Public contact
Name of contact person
| 1st name | Ken-ichi |
| Middle name | |
| Last name | Nagakura |
Organization
National Hospital Organization Sagamihara National Hospital
Division name
Department of pediatrics
Zip code
252-0392
Address
18-1, Sakuradai, Minamiku, Sagamihara City, Kanagawa, Japan, 252-0392
TEL
042-742-8311
Homepage URL
k.nagakura@foodallergy.jp
Sponsor or person
Institute
National Hospital Organization Sagamihara National Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development (AMED)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Hospital Organization Sagamihara National Hospital
Address
18-1, Sakuradai, Minamiku, Sagamihara City, Kanagawa, Japan, 252-0392
Tel
042-742-8311
222-rinri@mail.hosp.go.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
| 2018 | Year | 11 | Month | 08 | 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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 11 | Month | 08 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 11 | Month | 08 | Day |
Last modified on
| 2020 | Year | 11 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000039706
| 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 |
