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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000037708
Receipt No. R000043010
Scientific Title Effect of the natural bowel movement promotion on severely multiple handicapped children:Use soy bean flour yogurt infusion together with abdominal position, abdominal warming.
Date of disclosure of the study information 2019/11/30
Last modified on 2019/08/16

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Basic information
Public title Effect of the natural bowel movement promotion on severely multiple handicapped children:Use soy bean flour yogurt infusion together with abdominal position, abdominal warming.
Acronym Effect of the natural bowel movement promotion on severely multiple handicapped children.
Scientific Title Effect of the natural bowel movement promotion on severely multiple handicapped children:Use soy bean flour yogurt infusion together with abdominal position, abdominal warming.
Scientific Title:Acronym Effect of the natural bowel movement promotion on severely multiple handicapped children.
Region
Japan

Condition
Condition Constipation, Cerebral palsy
Classification by specialty
Nursing
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To promote a natural bowel movement.
To remove feelings of mental or physical pain using the enema.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Existence of natural defecation
Key secondary outcomes Reduction of abnormal symptoms of abdomen

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 ・Soy bean flour yogurt(Once a day)
・Prone position(Once a day)
・Hot compress(Once a day)
・30days
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
5 years-old <=
Age-upper limit
15 years-old >=
Gender Male and Female
Key inclusion criteria ・No natural defecation children with enema
・Prone everyday children
Key exclusion criteria Children with allergies
Target sample size 5

Research contact person
Name of lead principal investigator
1st name Michiko
Middle name
Last name Yanagisawa
Organization Social welfare corporation medical facilities for disabled children
Division name Nusing department
Zip code 350-0844
Address 1-1930Kamoda,Kawagoecity,Saitama Prefecture
TEL 049-229-5827
Email kango@karugamo.or.jp

Public contact
Name of contact person
1st name Michiko
Middle name
Last name Yanagisawa
Organization Social welfare corporation medical facilities for disabled children
Division name Nusing department
Zip code 350-0844
Address 1-1930Kamoda,Kawagoecity,Saitama Prefec
TEL 049-229-5827
Homepage URL
Email kango@karugamo.or.jp

Sponsor
Institute Social welfare corporation medical facilities for disabled children
Institute
Department

Funding Source
Organization Saitama Medical University General Medical Center Pediatrics
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Social welfare corporation medical facilities for disabled children
Address 1-1930Kamoda,Kawagoecity,Saitama Prefec
Tel 049-229-5827
Email kango@karugamo.or.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
2019 Year 11 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
2019 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2019 Year 10 Month 01 Day
Last follow-up date
2019 Year 11 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
2019 Year 08 Month 16 Day
Last modified on
2019 Year 08 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043010

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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