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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000023106
Receipt No. R000026628
Scientific Title Analysis of gut bacteria in feces sample for patients with constipation
Date of disclosure of the study information 2016/07/18
Last modified on 2018/04/10

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Basic information
Public title Analysis of gut bacteria in feces sample for patients with constipation
Acronym Gut bacteria in feces sample for patients with constipation (GBFC study)
Scientific Title Analysis of gut bacteria in feces sample for patients with constipation
Scientific Title:Acronym 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
1st name
Middle name
Last name Takahiro Yamasaki
Organization Yamaguchi University Graduate School of Medicine
Division name Department of Oncology and Laboratory Medicine
Zip code
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
1st name
Middle name
Last name Takahiro Yamasaki
Organization Yamaguchi University Graduate School of Medicine
Division name Department of Oncology and Laboratory Medicine
Zip code
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)

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
2016 Year 07 Month 18 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
2016 Year 04 Month 01 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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