UMIN-CTR Clinical Trial

Basic information
Public title	A single arm study of efficay of bifidobacterium for chronic constipation
Acronym	A feasile study of efficay of bifidobacterium for chronic constipation
Scientific Title	A single arm study of efficay of bifidobacterium for chronic constipation
Scientific Title:Acronym	A feasile study of efficay of bifidobacterium for chronic constipation
Region	Japan

Condition
Condition	chronic constipation
Classification by specialty	Medicine in general Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the efficacy of bifidobacterium for chronic constipation
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The change in JPAC-QOL score from pre-to after 8 weeks intervention
Key secondary outcomes	1,The comparison of JPAC-QOL score between at study entry,at 4 weeks drug intervention,at 8 weeks drug intervention and at 2 weeks after drug intervention(end of study) 2,The comparison of stool form,degree of sense of incomplete evacuation,degree of straining and frequency of internal use of rescue drugs between at study entry,at 4 weeks drug intervention,at 8 weeks drug intervention and at 2 weeks after drug intervention(end of study) 3, The change in profile of gut microbiome from pre-to after 8 weeks drug intervention 4,The drug compliance 5,The incidence rate of adverse events

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	bifidobacterium
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 bristol score 1 or 7 2, Patients who have fewer than one defecation per week 3, Patients who have obvious defecation disorders 4, Patients who have fewer than one of overall JPAC-QOL score 5, Patients who are excluded mechanical disorders by colonoscopy within five years 6, Patients who have severe complications 7, Patients who have history or current evidence of celiac disease or inflammatory bowel disease 8, Patients who are under treatment with steroid or biological products 9, Patients who have severe psychiatric disease 10, Patients who have current evidence of abuse of drugs or alcohol 11, Patients who have history of bifidobacteria allergies 12, Patients who had taken new drug therapy within 4 weeks before entry 13, Patients who had any change in types, dosage,or adiministration of their prescribed drugs within 4 weeks before entry 14, Patients who or are going to take new medicines 15, Patients who or are going to be participating in other clinical studies 16, Patients who are under treatment with other probiotics 17, Patients who are judged as inadequately for study entry
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Middle name Last name Atsushi Nakajima
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	nakajima-tky@umin.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Fuyuki Akiko
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	fuyuki-sin@umin.ac.jp

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

Funding Source
Organization	Biofermin Pharmacutical Co.,Ltd
Organization
Division
Category of Funding Organization	Profit organization
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	2017 Year 11 Month 15 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 06 Month 20 Day
Date of IRB	2017 Year 06 Month 20 Day
Anticipated trial start date	2017 Year 11 Month 14 Day
Last follow-up date	2019 Year 03 Month 27 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 11 Month 14 Day
Last modified on	2021 Year 08 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033915