UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031555 |
|---|---|
| Receipt number | R000036025 |
| Scientific Title | Study on the determination of the small intestine bacterial overgrowth by exhaled breath methane gas and hydrogen gas measurement |
| Date of disclosure of the study information | 2018/03/02 |
| Last modified on | 2023/03/31 17:08:43 |
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Basic information
Public title
Study on the determination of the small intestine bacterial overgrowth by exhaled breath methane gas and hydrogen gas measurement
Acronym
Study on the determination of the small intestine bacterial overgrowth by exhaled breath methane gas and hydrogen gas measurement
Scientific Title
Study on the determination of the small intestine bacterial overgrowth by exhaled breath methane gas and hydrogen gas measurement
Scientific Title:Acronym
Study on the determination of the small intestine bacterial overgrowth by exhaled breath methane gas and hydrogen gas measurement
Region
| Japan |
Condition
Condition
Functional gastrointestinal disorder
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate small intestinal bacterial overgrowth (SIBO) by glucose breath tests for hydrogen and methane in patients with functional gastrointestinal disorders.
Basic objectives2
Others
Basic objectives -Others
We investigate the frequency of SIBO in functional gastrointestinal disorders as compared to healthy adults. In addition, we evaluate the relationship between SIBO and each abdominal symptom.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
A peak hydrogen or methane value > 12 ppm above basal value after administration of 50g glucose is diagnosed as SIBO.
Key secondary outcomes
abdominal symptoms assessed by questionnaire for IBS.
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
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
glucose (50g) breath test
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
1) Patients with functional gastrointestinal disorder
2) Informed consent is obtained
3) Normal control: healthy volunteer
Key exclusion criteria
1) Patients who do not take breath test
ex. who cannot keep sitting position
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshikazu Kinoshita |
Organization
Shimane University Faculty of Medicine
Division name
Department of Internal Medicine 2
Zip code
Address
89-1 Enya-cho, Izumo, Shimane
TEL
0853-20-2190
kinosita@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Norihisa Ishimura |
Organization
Shimane University Faculty of Medicine
Division name
Department of Internal Medicine 2
Zip code
Address
89-1 Enya-cho, Izumo, Shimane
TEL
0853-20-2190
Homepage URL
ishimura@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
Shimane University Faculty of Medicine
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
Address
Tel
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
| 2018 | Year | 03 | Month | 02 | 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
Completed
Date of protocol fixation
| 2014 | Year | 11 | Month | 07 | Day |
Date of IRB
| 2014 | Year | 11 | Month | 07 | Day |
Anticipated trial start date
| 2014 | Year | 11 | Month | 07 | Day |
Last follow-up date
| 2023 | Year | 01 | 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
| 2018 | Year | 03 | Month | 02 | Day |
Last modified on
| 2023 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036025
