UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017786 |
|---|---|
| Receipt number | 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 23:54:14 |
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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
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
khosoi@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020540
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