UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019536
Receipt number R000018876
Scientific Title A Gastrointestinal Transit Study- clinical application of hydrogen breath test and Sitz marker test -
Date of disclosure of the study information 2015/10/28
Last modified on 2018/11/22 10:45:19

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Basic information

Public title

A Gastrointestinal Transit Study- clinical application of hydrogen breath test and Sitz marker test -

Acronym

hydrogen breath test and Sitz marker test

Scientific Title

A Gastrointestinal Transit Study- clinical application of hydrogen breath test and Sitz marker test -

Scientific Title:Acronym

hydrogen breath test and Sitz marker test

Region

Japan


Condition

Condition

Functional gastrointestinal disorders

Classification by specialty

Medicine in general Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Evaluation of gastrointestinal transit time

Basic objectives2

Bio-equivalence

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

To evaluate gastrointestinal transit time in patients with functional gastrointestinal disorders

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Self control

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Device,equipment

Interventions/Control_1

instrument to measure gastrointestinal transit time

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

10 years-old <=

Age-upper limit

80 years-old >=

Gender

Male and Female

Key inclusion criteria

patients with FGID who gave written informed consent

Key exclusion criteria

patients with FGID who did not give written informed consent

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Noriaki Manabe

Organization

Kawasaki Medical School

Division name

Division of Endoscopy and Ultrasonography, Department of Clinical Pathology and Laboratory Medicine

Zip code


Address

577 Matsushima, Kurashiki, Okayama, Japan

TEL

086-462-1111

Email

n_manabe@hkg.odn.ne.jp


Public contact

Name of contact person

1st name
Middle name
Last name Noriaki Manabe

Organization

Kawasaki Medical School

Division name

Division of Endoscopy and Ultrasonography, Department of Clinical Pathology and Laboratory Medicine

Zip code


Address

577 Matsushima, Kurashiki, Okayama, Japan

TEL

086-462-1111

Homepage URL


Email

n_manabe@hkg.odn.ne.jp


Sponsor or person

Institute

Kawasaki Medical School

Institute

Department

Personal name



Funding Source

Organization

Kawasaki Medical School

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan


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

川崎医科大学(岡山県)


Other administrative information

Date of disclosure of the study information

2015 Year 10 Month 28 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

Terminated

Date of protocol fixation

2015 Year 01 Month 24 Day

Date of IRB


Anticipated trial start date

2015 Year 01 Month 24 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 10 Month 28 Day

Last modified on

2018 Year 11 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018876


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name