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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034818
Receipt No. R000039706
Official scientific title of the study 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 2018/11/08

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Basic information
Official scientific title of the study Analysis of the efficacy of brown rice-specific gamma-oryzanol for children with constipation
Title of the study (Brief title) 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 Noriyuki Yanagida
Organization National Hospital Organization Sagamihara National Hospital
Division name Department of Pediatrics
Address 18-1, Sakuradai, Minamiku, Sagamihara City, Kanagawa, Japan, 252-0392
TEL 042-742-8311
Email sagamiharahospital@gmail.com

Public contact
Name of contact person Ken-ichi Nagakura
Organization National Hospital Organization Sagamihara National Hospital
Division name Department of pediatrics
Address 18-1, Sakuradai, Minamiku, Sagamihara City, Kanagawa, Japan, 252-0392
TEL 042-742-8311
Homepage URL
Email k-nagakura@sagamihara-hosp.gr.jp

Sponsor
Institute National Hospital Organization Sagamihara National Hospital
Institute
Department

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)

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

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2018 Year 11 Month 01 Day
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

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 11 Month 08 Day
Last modified on
2018 Year 11 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039706

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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