UMIN-CTR Clinical Trial

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

chronic constipation

Classification by specialty

Medicine in general

Gastroenterology

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Yokohama City University School of Medicine Department of Gastroenterology and Hepatology

Institute

Department

Personal name

Organization

Biofermin Pharmacutical Co.,Ltd

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2017

Year

11

Month

15

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2017

Year

11

Month

14

Day

Last modified on

2021

Year

08

Month

30

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033915