UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033715 |
|---|---|
| Receipt number | R000038443 |
| Scientific Title | Diagnosis and pathological analysis of intestinal bacterial overgrowth (SIBO) |
| Date of disclosure of the study information | 2018/08/10 |
| Last modified on | 2025/02/13 14:06:57 |
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Basic information
Public title
Diagnosis and pathological analysis of intestinal bacterial overgrowth (SIBO)
Acronym
SIBO
Scientific Title
Diagnosis and pathological analysis of intestinal bacterial overgrowth (SIBO)
Scientific Title:Acronym
SIBO
Region
| Japan |
Condition
Condition
small intestinal bacterial overgrowth
Classification by specialty
| Medicine in general | Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, intestinal fluid is collected and cultured by using upper gastrointestinal endoscopy to diagnose the presence or absence of abnormal growth of bacteria. In addition, the diagnostic ability of breath test is also assessed.
Basic objectives2
Others
Basic objectives -Others
Diagnostic ability
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The diagnostic ability (sensitivity, specificity, positive predictive value, negative predictive value) of breath test when quantitative culture of duodenal juice was taken as gold standard of SIBO diagnosis.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Those who visited Shiga University Medical School affiliated hospital
2. Those with abdominal symptoms such as abdominal distension and abdominal pain
3. Abdominal simple X-ray examination recognizes small intestinal gas or recognizes intestinal fecal sign by CT examination
4. Excluding organic diseases of the upper digestive tract is considered necessary, and those scheduled to undergo upper gastrointestinal endoscopy
5. Those who do not allow administration of antibiotics for at least 3 months prior to acquiring study participation consent
6. If probiotics has been prescribed, those that can be discontinued one week before entering intestinal fluid sampling and breath test
7. Those who can acquire the consent by free will from the principal in writing
Key exclusion criteria
8. Those who can not obtain consent
9. Diabetic patients who have poor glycemic control (in cases where marked hyperglycemia is expected with 50 g of glucose)
10. Those who are pregnant or suspected pregnancy
11. Those who have mental illness and have difficulty agreeing to this exam
12. What doctors deem inappropriate for participation in research
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Shigeki |
| Middle name | |
| Last name | BAMBA |
Organization
Shiga University of Medical Science
Division name
Division of Digestive Endoscopy
Zip code
5202192
Address
Seta-Tsukinowa
TEL
0775482618
sb@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | Shigeki |
| Middle name | |
| Last name | Bamba |
Organization
Shiga University of Medical Science
Division name
Division of Digestive Endoscopy
Zip code
5202192
Address
Seta-Tsukinowa
TEL
0775482618
Homepage URL
sb@belle.shiga-med.ac.jp
Sponsor or person
Institute
Shiga University of Medical Science
Institute
Department
Personal name
Funding Source
Organization
Shiga University of Medical Science
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shiga University of Medical Science
Address
Seta Tsukinowa Otsu
Tel
0775482217
sb@belle.shiga-med.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
| 2018 | Year | 08 | Month | 10 | 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
| 2018 | Year | 08 | Month | 10 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 09 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 10 | Day |
Last follow-up date
| 2028 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is an observational study.
Management information
Registered date
| 2018 | Year | 08 | Month | 10 | Day |
Last modified on
| 2025 | Year | 02 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038443
