UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000020540