UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044720 |
|---|---|
| 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 | 2024/05/30 10:20:58 |
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Basic information
Public title
Establishment of an evaluation method for electrogastoenterography in healthy volunteers
Acronym
Electrogastoenterography in healthy volunteers
Scientific Title
Establishment of an evaluation method for electrogastoenterography in healthy volunteers
Scientific Title:Acronym
Electrogastoenterography in healthy volunteers
Region
| Japan |
Condition
Condition
Adult healthy volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
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.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
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)
Key secondary outcomes
age, gender, height, weight, medical history
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
Prevention
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
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.
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy adults.
Key exclusion criteria
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.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yoshiaki |
| Middle name | |
| Last name | Inoue |
Organization
University of Tsukuba
Division name
Department of Emergency and Critical Care Medicine, Faculty of Medicine
Zip code
305-8575
Address
1-1-1 Tennodai, Tsukuba
TEL
029-853-3210
yinoue@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Gen |
| Middle name | |
| Last name | Aikawa |
Organization
University of Tsukuba
Division name
Comprehensive Human Sciences
Zip code
305-8575
Address
1-1-1 Tennodai, Tsukuba
TEL
080-2011-7440
Homepage URL
gen-aikawa@umin.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
University of Tsukuba
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
Tsukuba Clinical Research and Development Organization
Address
2-1-1, Amakubo, Tsukuba
Tel
029-853-3914
t-credo.adm@un.tsukuba.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
| 2021 | Year | 07 | Month | 01 | Day |
Related information
URL releasing protocol
None
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1155/2023/6902635
Number of participants that the trial has enrolled
50
Results
Gastric DF was not significantly different between pre- and postprandial. Small intestinal DF was also not significantly different between pre- and postprandial periods. Gastric DP increased significantly from before to after the meal. Small intestinal DF also increased significantly from before to after the meal. PR in the stomach and small intestine were 1.6 (0.9-2.5) and 1.4 (1.0-2.5), respectively, between pre- and postprandial periods.
Results date posted
| 2024 | Year | 05 | Month | 30 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The participants were 25 men (50%) with a median age of 34 years (IQR 27-42) and median height of 166 (158-172) cm. Median weight was 60 (51-68) kg and BMI was 21.5 (20.3-23.5) kg/m2. Time since last meal was 5.0 (4.5-11.3) hours and time since last bowel movement was 11.0 (5.0-20.0) hours. The median BSFS score recorded by the participants was 4 (4-4).
Participant flow
A total of 52 participants were recruited, but two participants whose EGG data were not suitable for analysis were excluded, and 50 participants were finally analyzed.
Adverse events
No occurrence
Outcome measures
Dominant Frequency, Proportion of dysrhythmias, Dominant Power, Power ratio.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 06 | Month | 24 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 29 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 06 | Month | 30 | Day |
Last modified on
| 2024 | Year | 05 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050609
