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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033715
Receipt No. R000038443
Official scientific title of the study Diagnosis and pathological analysis of intestinal bacterial overgrowth (SIBO)
Date of disclosure of the study information 2018/08/10
Last modified on 2018/08/10

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Basic information
Official scientific title of the study Diagnosis and pathological analysis of intestinal bacterial overgrowth (SIBO)
Title of the study (Brief title) 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 Shigeki BAMBA
Organization Shiga University of Medical Science
Division name Division of Clinical Nutrition
Address Seta-Tsukinowa
TEL 0775482899
Email sb@belle.shiga-med.ac.jp

Public contact
Name of contact person Shigeki Bamba
Organization Shiga University of Medical Science
Division name Division of Clinical Nutrition
Address Seta-Tsukinowa
TEL 0775482899
Homepage URL
Email sb@belle.shiga-med.ac.jp

Sponsor
Institute Shiga University of Medical Science
Institute
Department

Funding Source
Organization Shiga University of Medical Science
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

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

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2018 Year 08 Month 10 Day
Anticipated trial start date
2018 Year 08 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information This is an observational study.

Management information
Registered date
2018 Year 08 Month 10 Day
Last modified on
2018 Year 08 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038443

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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