UMIN-CTR Clinical Trial

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
Email	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
Email	atsuda@belle.shiga-med.ac.jp

Sponsor
Institute	Shiga University of Medical Science
Institute
Department

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
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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000040706