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 2021/08/12 13:24:15

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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

Email

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


Email

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



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

Email

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

2023 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

2021 Year 08 Month 12 Day



Link to view the page

Value
https://center6.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