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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033259
Receipt No. R000037915
Scientific Title The study of gut microbiota modulation by elobixibat in chronic constipation
Date of disclosure of the study information 2018/07/09
Last modified on 2019/01/09

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Basic information
Public title The study of gut microbiota modulation by elobixibat in chronic constipation
Acronym The study of gut microbiota modulation by elobixibat in chronic constipation
Scientific Title The study of gut microbiota modulation by elobixibat in chronic constipation
Scientific Title:Acronym The study of gut microbiota modulation by elobixibat in chronic constipation
Region
Japan

Condition
Condition Chronic constipation
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess gut microbiota modulation by increase of bile acid in the colon
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Gut microbiota modulation from baseline to 2 weeks
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 The patients receive oral elobixibat 10mg trice per day after meals for 2 weeks
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
80 years-old >
Gender Male and Female
Key inclusion criteria (1) Patients who are diagnosed chronic constipation by ROME criteria
(2) Patients who can exhibit their consent in a document
Key exclusion criteria (1) Patients who have severe complications
(2) Patients who were administered elobixibat or antibiotics within 1 month
(3) Patients who have history of elobixibat allergies

(4) Patients who have bristol score 7
(5) Patients who have severe psychiatric disease
(6) Patients who have current evidence of abuse of drugs or alcohol
(7) Patients who or are going to take new medicines
(8) Patients who or are going to be participating in other clinical studies
(9) Patients who are judged as inadequately for study entry
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Noboru Misawa
Organization Yokohama City University school of medicine
Division name Department of gastroenterology and hepatology
Zip code
Address 3-9 Fukuura Kanazawa-ku Yokohama City
TEL 045-787-2640
Email misawa-ykh@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Noboru Misawa
Organization Yokohama City University school of medicine
Division name Department of gastroenterology and hepatology
Zip code
Address 3-9 Fukuura Kanazawa-ku Yokohama City
TEL 045-787-2640
Homepage URL
Email misawa-ykh@umin.ac.jp

Sponsor
Institute Yokohama City University School of Medicine Department of Gastroenterology and Hepatology
Institute
Department

Funding Source
Organization Yokohama City University School of Medicine Department of Gastroenterology and Hepatology
Organization
Division
Category of Funding Organization Other
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
2018 Year 07 Month 09 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 Open public recruiting
Date of protocol fixation
2018 Year 06 Month 28 Day
Date of IRB
Anticipated trial start date
2018 Year 07 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information None

Management information
Registered date
2018 Year 07 Month 03 Day
Last modified on
2019 Year 01 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037915

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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