UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A Gastrointestinal Transit Study- clinical application of hydrogen breath test and Sitz marker test -
Title of the study (Brief title)	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	Noriaki Manabe
Organization	Kawasaki Medical School
Division name	Division of Endoscopy and Ultrasonography, Department of Clinical Pathology and Laboratory Medicine
Address	577 Matsushima, Kurashiki, Okayama, Japan
TEL	086-462-1111
Email	n_manabe@hkg.odn.ne.jp

Public contact
Name of contact person	Noriaki Manabe
Organization	Kawasaki Medical School
Division name	Division of Endoscopy and Ultrasonography, Department of Clinical Pathology and Laboratory Medicine
Address	577 Matsushima, Kurashiki, Okayama, Japan
TEL	086-462-1111
Homepage URL
Email	n_manabe@hkg.odn.ne.jp

Sponsor
Institute	Kawasaki Medical School
Institute
Department

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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2015 Year 01 Month 24 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018876