UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028246 |
|---|---|
| Receipt number | R000032325 |
| Scientific Title | Assessment of autonomic nervous system function by using wearable device in patients with functional gastrointestinal disorders |
| Date of disclosure of the study information | 2017/07/14 |
| Last modified on | 2023/01/17 13:39:46 |
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Basic information
Public title
Assessment of autonomic nervous system function by using wearable device in patients with functional gastrointestinal disorders
Acronym
Autonomic function analysis by using wearable device in FGIDs
Scientific Title
Assessment of autonomic nervous system function by using wearable device in patients with functional gastrointestinal disorders
Scientific Title:Acronym
Autonomic function analysis by using wearable device in FGIDs
Region
| Japan |
Condition
Condition
Functional dyspepsia, Irritable bowel syndrome
Classification by specialty
| Medicine in general | Hepato-biliary-pancreatic medicine | Psychosomatic Internal Medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the pathophysiology of functional gastrointestinal disorders by the analysis of the relationship between autonomic nervous system function and gastrointestinal symptoms.
Basic objectives2
Others
Basic objectives -Others
None
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The change amounts of autonomic nervous system function during the presence of clinical symptoms
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with functional gastrointestinal disorders who meet criteria for Rome IV
Key exclusion criteria
Subjects who have the history of gastrointestinal operation
Subjects who have pacemaker and implantable cardioverter defibrillator
Subjects who is considered as ineligible by the physician
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Fumio |
| Middle name | |
| Last name | Tanaka |
Organization
Osaka City University Graduate School of Medicine
Division name
Gastroenterology
Zip code
5458585
Address
1-4-3 Asahimachi, Abeno-ku, Osaka city, Osaka
TEL
06-6645-3811
m2079981@med.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | Fumio |
| Middle name | |
| Last name | Tanaka |
Organization
Osaka City University Graduate School of Medicine
Division name
Gastroenterology
Zip code
5458585
Address
1-4-3 Asahimachi, Abeno-ku, Osaka city, Osaka
TEL
06-6645-3811
Homepage URL
m2079981@med.osaka-cu.ac.jp
Sponsor or person
Institute
Osaka City University
Institute
Department
Personal name
Funding Source
Organization
Wellness Open Living Lab. LLC
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka City University Review Board
Address
1-2-7, Asahimachi, Abeno-ku, Osaka city, Osaka
Tel
06-6646-6125
ethics@med.osaka-cu.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
| 2017 | Year | 07 | Month | 14 | Day |
Related information
URL releasing protocol
PLoS One. 2022 Dec 9;17(12):e0278922. doi: 10.1371/journal.pone.0278922.
Publication of results
Published
Result
URL related to results and publications
PLoS One. 2022 Dec 9;17(12):e0278922. doi: 10.1371/journal.pone.0278922.
Number of participants that the trial has enrolled
90
Results
In patients with IBS, sympathetic nerve activity was activated 2 min before defecation, which was correlated with abdominal symptoms and lower QOL.
Results date posted
| 2023 | Year | 01 | Month | 17 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
This was a prospective multicenter study in which patients with IBS visiting Osaka City University and Osaka Medical and Pharmaceutical University participated between July 2018 and May 2019.
Participant flow
This was a prospective multicenter study in which patients with IBS visiting Osaka City University and Osaka Medical and Pharmaceutical University participated between July 2018 and May 2019.
Adverse events
None
Outcome measures
The main outcome was changes in the autonomic nervous function before and after defecation, which were compared between the control and IBS groups. Other measured values of autonomic nervous function were compared as secondary outcomes. Furthermore, correlations between the measured values of autonomic nervous function, symptom scores, and QOL scores were evaluated.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2017 | Year | 06 | Month | 16 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 04 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 14 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We obtain biological information such as autonomic nervous system function by wearing device for 24 hours. We also obtain the information about gastrointestinal symptoms, defecation, and sleep by using the application software on the smartphone.
Management information
Registered date
| 2017 | Year | 07 | Month | 14 | Day |
Last modified on
| 2023 | Year | 01 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032325
