UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013545 |
|---|---|
| Receipt number | 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 10:15:29 |
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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
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
shimurashino@yahoo.co.jp
Sponsor or person
Institute
Shimane University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015825
