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

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 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


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

Value
https://center6.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