UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058206 |
|---|---|
| Receipt number | R000066507 |
| Scientific Title | Prospective Study on Abdominal Ultrasonographic Findings and Abdominal Symptoms |
| Date of disclosure of the study information | 2025/06/18 |
| Last modified on | 2025/06/18 00:16:39 |
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Basic information
Public title
A Study Exploring the Relationship Between Abdominal Ultrasound Findings and Abdominal Symptoms
Acronym
AUAS Study
Scientific Title
Prospective Study on Abdominal Ultrasonographic Findings and Abdominal Symptoms
Scientific Title:Acronym
AUAS Study
Region
| Japan |
Condition
Condition
Patients with abdominal symptoms (functional dyspepsia, gastroparesis, irritable bowel syndrome, chronic constipation) and healthy volunteers
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To perform a visual and objective evaluation of intestinal content volume and localization using abdominal ultrasonography and investigate their relationship with abdominal symptoms. A comparative analysis will be conducted of intestinal content volume, bowel diameter, peristalsis, and evacuation function before and after a test meal in healthy individuals and patients with abdominal symptoms.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of gastric content volume, bowel diameter, peristaltic activity, and evacuation function before and after a test meal between healthy individuals and patients with abdominal symptoms
Key secondary outcomes
Relationship between gastric volume, diameter, peristalsis, and abdominal symptom before and after the test meal, evaluation of gastric emptying
The relationship between abdominal ultrasound findings, patient background, and abdominal symptoms
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Food |
Interventions/Control_1
test meal
Interventions/Control_2
test meal
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with abdominal symptoms (functional gastrointestinal disease) who have undergone Upper endoscopy or upper gastrointestinal barium examination and are excluded from organic diseases.
or healthy subjects without abdominal symptoms.
Written informed consent provided for study participation
Key exclusion criteria
Patients with organic gastrointestinal diseases (e.g., active peptic ulcer, inflammatory bowel disease)
Patients who have undergone gastrointestinal tract resection
Patients with advanced gastric cancer or advanced colorectal cancer
Patients with allergies to the test meal
Individuals deemed unsuitable for inclusion in the study by the principal investigator for any other reason
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Tsutomu |
| Middle name | |
| Last name | Takeda |
Organization
Juntendo university school of medicine
Division name
Department of Gastroenterology
Zip code
113-8421
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo
TEL
0338133111
t-takeda@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Tsutomu |
| Middle name | |
| Last name | Takeda |
Organization
Juntendo university school of medicine
Division name
Department of Gastroenterology
Zip code
113-8421
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo
TEL
0338133111
Homepage URL
t-takeda@juntendo.ac.jp
Sponsor or person
Institute
Juntendo university
Institute
Department
Personal name
Funding Source
Organization
Self-funded
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Juntendo University school of Medicine Ethics Committee
Address
3-1-3 Hongo, Bunkyo-ku
Tel
03-5802-1584
kenkyu5858@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
| 2025 | Year | 06 | Month | 18 | 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
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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 06 | Month | 03 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 03 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 03 | Day |
Last follow-up date
| 2027 | 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
| 2025 | Year | 06 | Month | 18 | Day |
Last modified on
| 2025 | Year | 06 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066507
