UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Analysis of gut bacteria in feces sample for patients with constipation
Title of the study (Brief title)	Gut bacteria in feces sample for patients with constipation (GBFC study)
Region	Japan

Condition
Condition	Patients with constipation according to ROME III criteria
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We analyzed gut bacteria in feces sample for patients with constipation before and after laxative.
Basic objectives2	Others
Basic objectives -Others	Changes of gut bacteria before and after laxative
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Changes of gut bacteria before and after laxative
Key secondary outcomes	Analysis of gut bacteria in patients with constipation

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	1. Patients with constipation who will treat with laxative 2. Patients with colorectal cancer suspition due to organic constipation 3. More than or equal to 20 years-old, male and female 4. Imformed consent was obtained before entry of this study. 5. Outpatient and inpatient
Key exclusion criteria	1. Patients with another active cancer except for colorectal cancer 2. Past history of colorectal cancer 3. Patients who treated with oral or intravenous antibiotic drug one month before an acquirement of informed consent 4. Patients whom the doctor judged as ineligible due to other reseans
Target sample size	100

Research contact person
Name of lead principal investigator	Takahiro Yamasaki
Organization	Yamaguchi University Graduate School of Medicine
Division name	Department of Oncology and Laboratory Medicine
Address	1-1-1 Minamikogushi, Ube, Yamaguchi 755-8505, Japan
TEL	0836-22-2337
Email	t.yama@yamaguchi-u.ac.jp

Public contact
Name of contact person	Takahiro Yamasaki
Organization	Yamaguchi University Graduate School of Medicine
Division name	Department of Oncology and Laboratory Medicine
Address	1-1 Minamikogushi, Ube, Yamaguchi 755-8505, Japan
TEL	0836-22-2337
Homepage URL
Email	t.yama@yamaguchi-u.ac.jp

Sponsor
Institute	Yamaguchi University Hospital
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information	2016 Year 07 Month 18 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2016 Year 04 Month 01 Day
Anticipated trial start date	2016 Year 07 Month 18 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	1. Fecal occult blood test before therapy 2. Changes of fecal gut bacteria before and after laxative 3. Fecal DNA methylation 4. Findings of colonoscopy and pathology

Management information
Registered date	2016 Year 07 Month 11 Day
Last modified on	2018 Year 04 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026628