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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000013545
Receipt No. R000015825
Scientific Title Evaluation of small intestinal bacterial overgrowth by hydrogen breath test
Date of disclosure of the study information 2014/03/28
Last modified on 2014/08/06

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Basic information
Public title Evaluation of small intestinal bacterial overgrowth by hydrogen breath test
Acronym Evaluation of small intestinal bacterial overgrowth by hydrogen breath test
Scientific Title Evaluation of small intestinal bacterial overgrowth by hydrogen breath test
Scientific Title:Acronym Evaluation of small intestinal bacterial overgrowth by hydrogen breath test
Region
Japan

Condition
Condition patients who complained of abdominal discomfort with negative endoscopy/radiology test
Classification by specialty
Medicine in general Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We sought to evaluate the effectiveness of glucose hydrogen breath test for diagnosing SIBO(small intestinal bacterial overgrowth).
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes a rise in breath hydrogen by 10 ppm above the basal among 60-120 minitues after ingested 50 g of glucose in 300 ml water
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

Not applicable
Gender Male and Female
Key inclusion criteria Patients who complained of abdominal discomfort ,as abdominal pain, diarrhea and constipation, with negative endoscopy/radiology test and laboratory data were enrolled.
Key exclusion criteria severe diabetes mellitus
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshikazu Kinoshita
Organization Shimane University School of Medicine
Division name department of Gastroenterology and Hepatology
Zip code
Address 89-1 Enya-cho, Izumo, Shimane 693-8501, Japan
TEL 0853-20-2190
Email shimurashino@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Norihisa Ishimura
Organization Shimane University School of Medicine
Division name department of Gastroenterology and Hepatology
Zip code
Address 89-1 Enya-cho, Izumo, Shimane 693-8501, Japan
TEL 0853-20-2190
Homepage URL
Email shimurashino@yahoo.co.jp

Sponsor
Institute Shimane University School of Medicine
Institute
Department

Funding Source
Organization Shimane University School of Medicine
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2014 Year 03 Month 28 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2010 Year 12 Month 27 Day
Date of IRB
Anticipated trial start date
2010 Year 12 Month 27 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information prospective study

Management information
Registered date
2014 Year 03 Month 28 Day
Last modified on
2014 Year 08 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015825

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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