UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030147 |
|---|---|
| Receipt number | R000034432 |
| Scientific Title | Modification of Neurotransmission of Brain-Gut Interactions |
| Date of disclosure of the study information | 2018/04/01 |
| Last modified on | 2017/11/28 12:12:05 |
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Basic information
Public title
Modification of Neurotransmission of Brain-Gut Interactions
Acronym
Neuro-modification of Brain-Gut
Scientific Title
Modification of Neurotransmission of Brain-Gut Interactions
Scientific Title:Acronym
Neuro-modification of Brain-Gut
Region
| Japan |
Condition
Condition
irritable bowel syndrome
healthy controls
Classification by specialty
| Medicine in general | Gastroenterology | Psychosomatic Internal Medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to test our hypothesis that brain-gut interactions in individuals with irritable bowel syndrome (IBS) is different from those in healthy controls.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
brain images of positron emission tomography (PET)
Key secondary outcomes
ordinate scale
psychometric tests
plasma/serum hormones
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
6
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
saline
intravenous administration
one time
Interventions/Control_2
CRH
intravenous administration
one time
Interventions/Control_3
alpha-helical CRH
intravenous administration
one time
Interventions/Control_4
ramosetron
intravenous administration
one time
Interventions/Control_5
naloxone
intravenous administration
one time
Interventions/Control_6
asimadoline
intravenous administration
one time
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Rome III/IV
Asymptomatic healthy individual
Key exclusion criteria
organic diseases
psychiatric diseases
Target sample size
240
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shin Fukudo, MD, PhD |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Behavioral Medicine
Zip code
Address
2-1 Seiryo, Aoba, Sendai 980-8575, Japan
TEL
022-717-8162
sfukudo@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shin Fukudo, MD, PhD |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Behavioral Medicine
Zip code
Address
2-1 Seiryo, Aoba, Sendai 980-8575, Japan
TEL
022-717-8162
Homepage URL
sfukudo@med.tohoku.ac.jp
Sponsor or person
Institute
Department of Behavioral Medicine,
Tohoku University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
JSPS/MEXT
AMED/MHLW
Institutional Grant
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
東北大学大学院医学系研究科
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Enrolling by invitation
Date of protocol fixation
| 2010 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
| 2022 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
| 2022 | Year | 11 | Month | 30 | Day |
Date analysis concluded
| 2022 | Year | 11 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 11 | Month | 28 | Day |
Last modified on
| 2017 | Year | 11 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034432
