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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017786
Receipt No. R000020540
Scientific Title Prostective evaluation study for establishing treatment of pediatric fuctional gstrointestinal disorder and orthostatic disregulation patients
Date of disclosure of the study information 2015/07/01
Last modified on 2020/06/07

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Basic information
Public title Prostective evaluation study for establishing treatment of pediatric fuctional gstrointestinal disorder and orthostatic disregulation patients
Acronym Study for establishing treatment in pediatric fuctional gastrointestinal disorder patients
Scientific Title Prostective evaluation study for establishing treatment of pediatric fuctional gstrointestinal disorder and orthostatic disregulation patients
Scientific Title:Acronym Study for establishing treatment in pediatric fuctional gastrointestinal disorder patients
Region
Japan

Condition
Condition pediatric functional gastrointestinal disorders
Orthostatic dysregulation
Classification by specialty
Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To elucidate the pathogenesis of pediatric gastrointestinal disorders
Basic objectives2 Others
Basic objectives -Others To establish the examinations and treatments in pediatric functional gastrointestinal disorders
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes To evaluate emptying and peristalsis of stomach
To evaluate small intestinal bacterial overgrowth
Key secondary outcomes autonomic nervous function, cognitive assessment, psycological assessment, Quality of life assessment, stress assessment

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 Diagnosis
Type of intervention
Device,equipment Other
Interventions/Control_1 1.Hydrogen Breath Tests
At the start of the test, fasting breath hydrogen is estimated 3 to 4 times. Subsequently, the subject ingests a fixed amount of gulucose(1g/kg, max100g).

2.13C-acetate Breath Test
At the start of the test, fasting breath is measured. Subsequently, the subject ingests a fixed amount of 13C-acetate 100mg and Racol 200ml.

3.Electrogastrography
Electrogastrography recordings was obtained for 30 min in the fasting state and for another 30 min after a test meal, Racol 200ml.
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
6 years-old <=
Age-upper limit
20 years-old >
Gender Male and Female
Key inclusion criteria <Functional gastrointestinal disorders>
Must include all of the following.
1.At obtaining informed consent, => 6 y.o and < 20 y.o
2.Based on ROMA 3 criteria, diagnosed as fuctional gastrointestinal disorders
3.It is possible to cease treatment affecting gastrointestinal function, autonomic nerve system and psycosocial factors
4.No evidence of respiratory disease and liver disease
5.No history of gastrointestinal surgery
6.Not suffering from acute disorders such as upper respiratory inflammatory and acute gastroenteritis
7.After receiving a sufficient explanation, obtained from patients or legal representative informed consent

<Orthostatic dysregulation patients>
Must include all of the following.
1.At obtaining informed consent, => 6 y.o and < 20 y.o
2.Must fulfill criteria by standing test
3.No evidence of structural disease
4.It is possible to cease treatment
5.Not suffering from acute disorders such as upper respiratory inflammatory and acute gastroenteritis
6.After receiving a sufficient explanation, obtained from patients or legal representative informed consent
Key exclusion criteria Include one or more of the following.
1.At informed consent, < 6 y.o and => 20y.o
2.It is impossible to cease treatment
3.History of gastrointestinal surgery
4.It is impossible to communicate
5.Determined to inappreciate by investigator
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Toshiaki
Middle name
Last name Shimizu
Organization Juntendo University
Division name Pediatrics and Adolescent Medicine
Zip code 113-8421
Address Hongo 2-1-1, Bunkyo, Tokyo
TEL 03-3813-3111
Email tshimizu@juntendo.ac.jp

Public contact
Name of contact person
1st name Kenji
Middle name
Last name Hosoi
Organization Juntendo University
Division name Pediatrics and Adolescent Medicine
Zip code 113-8421
Address Hongo 2-1-1, Bunkyo, Tokyo
TEL 03-3813-3111
Homepage URL
Email khosoi@juntendo.ac.jp

Sponsor
Institute Juntendo University
Institute
Department

Funding Source
Organization Juntendo University research funding
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 The ethics committee of Juntendo Univercity
Address Hongo 2-1-1, Bunkyo, Tokyo
Tel 03-5802-1584
Email hmasuko@juntendo.ac.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
2015 Year 07 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 20
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 Completed
Date of protocol fixation
2015 Year 05 Month 19 Day
Date of IRB
2015 Year 05 Month 22 Day
Anticipated trial start date
2015 Year 07 Month 01 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
2020 Year 03 Month 31 Day
Date trial data considered complete
2020 Year 03 Month 31 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 06 Month 03 Day
Last modified on
2020 Year 06 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020540

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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