UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035733 |
|---|---|
| Receipt number | R000040706 |
| Scientific Title | Analysis of microbiota in patients with chronic constipation. |
| Date of disclosure of the study information | 2019/01/31 |
| Last modified on | 2020/09/01 04:19:55 |
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Basic information
Public title
Analysis of microbiota in patients with chronic constipation.
Acronym
Intestinal microbiota and chronic constipation
Scientific Title
Analysis of microbiota in patients with chronic constipation.
Scientific Title:Acronym
Intestinal microbiota and chronic constipation
Region
| Japan |
Condition
Condition
Chronic constipation
Classification by specialty
| Gastroenterology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the influence of intestinal microbiota in constipation patients
Basic objectives2
Others
Basic objectives -Others
Analysis of the difference between the fecal and mucosa-associated microbiota
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Composition of intestinal microbiota
Key secondary outcomes
Comparison of microbiota in fecal samples and mucosa-associated microbiota, past treatments, analysis of urine rotting products, relation with medical history
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) Adult over 20 years old patients who are undergoing colonoscopy in Shiga university of medical science hospital or Kusatsu general hospital.
2) Written informed consent.
3) Patients who are diagnosed chronic constipation by ROME4 criteria
4) Patients who are not diagnosed chronic constipation by ROME4 criteria
Key exclusion criteria
1)Patients who are diagnosed colon cancer
2)Patients who are receiving anticoaglant medication or having bleeding tendency
3)Patients without informed consent
4)Patients who have the infection that the report based on the infection method needs
5)Patients who had received antibiotics or probiotics within 1 month
6)Patients who are regarded in-eligible by the doctor who participates in this study
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Atsushi Nishida |
Organization
Shiga University of Medical Science
Division name
Division of Gastroenterology
Zip code
Address
Seta Tsukinowa, Otsu, Shiga
TEL
077-548-2217
atsuda@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Atsushi Nishida |
Organization
Shiga University of Medical Science
Division name
Division of Gastroenterology
Zip code
Address
Seta Tsukinowa, Otsu, Shiga
TEL
077-548-2217
Homepage URL
atsuda@belle.shiga-med.ac.jp
Sponsor or person
Institute
Shiga University of Medical Science
Institute
Department
Personal name
Funding Source
Organization
Shiga University of Medical Science
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
| 2019 | Year | 01 | Month | 31 | 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
Completed
Date of protocol fixation
| 2017 | Year | 10 | Month | 31 | Day |
Date of IRB
| 2017 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2019 | Year | 01 | Month | 31 | Day |
Last modified on
| 2020 | Year | 09 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040706
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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