Unique ID issued by UMIN | UMIN000044720 |
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Receipt number | R000050609 |
Scientific Title | Establishment of an evaluation method for electrogastoenterography in healthy volunteers |
Date of disclosure of the study information | 2021/07/01 |
Last modified on | 2023/09/16 21:27:49 |
Establishment of an evaluation method for electrogastoenterography in healthy volunteers
Electrogastoenterography in healthy volunteers
Establishment of an evaluation method for electrogastoenterography in healthy volunteers
Electrogastoenterography in healthy volunteers
Japan |
Adult healthy volunteers
Adult |
Others
NO
To investigate the possibility of quantitative evaluation of gastrointestinal peristalsis by electrogastroenterography in healthy volunteers, and to establish a measurement method by quantitative evaluation of changes in electrogastroenterography caused by feeding.
Efficacy
Confirmatory
Others
Not applicable
electrogastroenterography parameters (dominant frequency [DF], dominant power [DP], power ratio [ratio of DP before and after feeding], share of normal wave/slow wave/fast wave/rhythm irregular wave, dominant frequency instability coefficient (DFIC), dominant power instability coefficient (DPIC)), defecation status (nature and volume), Japanese version of Patient Assessment of Constipation of Quality of Life Scale (PAC-QOL)
age, gender, height, weight, medical history
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Prevention
Food | Behavior,custom |
To compare the electrogastroenterography before and after feeding, a feeding intervention will be performed. A solid meal (two rice balls) with a calorific value of about 400 kcal will be used.
The patient should fast for 4 hours before the electrogastroenterography and drink water up to 2 hours before the measurement.
The Electrogastroenterography will be measured for 30 minutes before feeding and 30 minutes after feeding.
20 | years-old | <= |
65 | years-old | >= |
Male and Female
Healthy adults.
Gastrointestinal disorders such as irritable gastroenteritis and inflammatory bowel disease, history of gastrointestinal surgery, diabetes mellitus, autonomic neuropathy of any etiology, including Parkinson's disease, taking gastrointestinal peristalsis medication within the last 48 hours.
50
1st name | Yoshiaki |
Middle name | |
Last name | Inoue |
University of Tsukuba
Department of Emergency and Critical Care Medicine, Faculty of Medicine
305-8575
1-1-1 Tennodai, Tsukuba
029-853-3210
yinoue@md.tsukuba.ac.jp
1st name | Gen |
Middle name | |
Last name | Aikawa |
University of Tsukuba
Comprehensive Human Sciences
305-8575
1-1-1 Tennodai, Tsukuba
080-2011-7440
gen-aikawa@umin.ac.jp
University of Tsukuba
University of Tsukuba
Japanese Governmental office
Tsukuba Clinical Research and Development Organization
2-1-1, Amakubo, Tsukuba
029-853-3914
t-credo.adm@un.tsukuba.ac.jp
NO
2021 | Year | 07 | Month | 01 | Day |
Published
https://doi.org/10.1155/2023/6902635
50
Completed
2021 | Year | 06 | Month | 24 | Day |
2021 | Year | 06 | Month | 29 | Day |
2021 | Year | 07 | Month | 01 | Day |
2022 | Year | 12 | Month | 31 | Day |
2021 | Year | 06 | Month | 30 | Day |
2023 | Year | 09 | Month | 16 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050609
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