UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052609 |
|---|---|
| Receipt number | R000060033 |
| Scientific Title | Investigation of the usefulness of the aldehyde breath test with respect to gastrointestinal diseases |
| Date of disclosure of the study information | 2023/11/01 |
| Last modified on | 2023/10/25 15:32:48 |
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Basic information
Public title
Investigation of the usefulness of the aldehyde breath test with respect to gastrointestinal diseases
Acronym
Investigation of the usefulness of the aldehyde breath test with respect to gastrointestinal diseases
Scientific Title
Investigation of the usefulness of the aldehyde breath test with respect to gastrointestinal diseases
Scientific Title:Acronym
Investigation of the usefulness of the aldehyde breath test with respect to gastrointestinal diseases
Region
| Japan |
Condition
Condition
gastrointestinal disorder
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To analyze the association between gastrointestinal diseases and ALDH2 gene polymorphisms in patients with gastrointestinal diseases (gastrointestinal, liver, and biliopancreatic diseases) who are attending or being admitted to the Department of Gastroenterology, Kagoshima University Hospital, we will measure trace acetaldehyde/ethanol in the breath of patients using breath samples collected from them.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Trace amount of acetaldehyde/ethanol in expired breath by breath test
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
A special aero-chroma drink (100 mL of soft drink 0.5% ethanol water) is ingested, and the exhaled breath is collected 1 minute later using an exhaled breath bag.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Subjects: Patients 20 years of age or older at the time of consent
Gender: any gender
Inpatient/Outpatient: Outpatients and inpatients
No alcohol allergy
Not planning to drive a car on the day of the test
Key exclusion criteria
Allergic to alcohol or intolerant to alcohol
Other patients deemed unsuitable as subjects by the person in charge
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Shinichi |
| Middle name | |
| Last name | Hashimoto |
Organization
Kagoshima University Hospital
Division name
Division of Endoscopy
Zip code
8908520
Address
8-35-1 Sakuragaoka, Kagoshima City, Kagoshima Prefecture
TEL
099-275-5326
kumdsh@m.kufm.kagoshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Shinichi |
| Middle name | |
| Last name | Hashimoto |
Organization
Kagoshima University Hospital
Division name
Optical Medical Treatment Department
Zip code
8908520
Address
8-35-1 Sakuragaoka, Kagoshima City, Kagoshima Prefecture
TEL
0992755326
Homepage URL
kumdsh@m.kufm.kagoshima-u.ac.jp
Sponsor or person
Institute
Kagoshima University
Institute
Department
Personal name
Funding Source
Organization
Kagoshima University
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
Kagoshima University Hospital Clinical Research Management Center
Address
8-35-1 Sakuragaoka, Kagoshima
Tel
099-275-6624
crmc@m2.kufm.kagoshima-u.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
| 2023 | Year | 11 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 02 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 08 | 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
| 2023 | Year | 10 | Month | 25 | Day |
Last modified on
| 2023 | Year | 10 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060033
