UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023106 |
|---|---|
| Receipt number | 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 13:11:19 |
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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
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
t.yama@yamaguchi-u.ac.jp
Sponsor or person
Institute
Yamaguchi University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026628
