UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020990
Receipt number R000024231
Scientific Title Effect of Lactobacillus brevis KB290 on bowel movement and on microbiota in subjects with a tendetendency toward constipation: a randomized, double-blind, placebo-controlled, parallel-group trial.
Date of disclosure of the study information 2016/02/14
Last modified on 2018/08/16 10:31:20

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Basic information

Public title

Effect of Lactobacillus brevis KB290 on bowel movement and on microbiota in subjects with a tendetendency toward constipation: a randomized, double-blind, placebo-controlled, parallel-group trial.

Acronym

Effect of Lactobacillus brevis KB290 on bowel movement and microbiota.

Scientific Title

Effect of Lactobacillus brevis KB290 on bowel movement and on microbiota in subjects with a tendetendency toward constipation: a randomized, double-blind, placebo-controlled, parallel-group trial.

Scientific Title:Acronym

Effect of Lactobacillus brevis KB290 on bowel movement and microbiota.

Region

Japan


Condition

Condition

people tend to be constipated

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the effect of intervention with Lactobacillus brevis KB290 on bowel movement in subjects with a tendency of constipation.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Defecation frequency and days of defecation per week or 2 weeks will be measured. The changes will be compared within each group and between the treatment groups.

Key secondary outcomes

Amount of defecation, Bristol Stool Form Scale, stool color and smell, feeling after defecation will be measured. Also, variety and ratio of bacteria in stool (intestinal microbiota) will be measured. The changes will be compared within each group and between the treatment groups.


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

YES

Dynamic allocation


Institution consideration


Blocking


Concealment

No need to know


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

A capsule containing Lactobacillus brevis KB290 per day for 2 weeks.

Interventions/Control_2

A placebo capsule (not containing Lactobacillusu brevis KB290) per day for 2 weeks.

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

60 years-old >

Gender

Male and Female

Key inclusion criteria

People whose defecation frequency is no fewer than 3, nor more than 5, and who usually have three meals a day.
(Who gave the informed consents in writing after receiving enough explanation of the purpose and detail of the study, understanding the study well, and deciding to attend the study with their own will.)

Key exclusion criteria

People who meet any of the following conditions will be excluded.
1) Who regularly use intestinal drugs and laxatives (including strong laxatives).
2) Who can't stop intake food containing viable bacteria such as Lactic acid bacteria, Bifidobacteria, Natto bacteria and/or enhanced with oligosaccharide, dietary fiber and/or the health food to relieve constipation (including Food for Specified Health Uses (FOSHU)) and/or containing a large amount of sugar alcohol during this study.
3) Who habitually consume higher amount of alcohol (more than 1000 mL in terms of beer per day).
4) Who use medicine such as antibiotics that affect digestion and absorption.
5) Who have allergic to food.
6) Who is pregnant or willing to be pregnant or breast-feeding during this study.
7) Who are participated in other clinical trials that intake/apply any of food, drug, and cosmetics, or willing to be that.
8) Who have serious diseases requiring an urgent treatment, or who accept severe complication.
9) Who has a medical history of diseases or surgeries affecting digestion, absorption and bowel movement (except for appendicectomy).
10) Who has a current or history of drug dependence and/or alcoholism.
11) Who has ever been diagnosed with Irritable Bowel Syndrome (IBS) or Inflammatory Bowel Disease (IBD).
12) Who has an irregular menstrual cycle, or is undergoing treatment for menopause.
13) Who are judged unsuitable for this study based onsubject questionnaire.
14) Who are judged unsuitable for this study by principal investigator.

Target sample size

130


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Satoshi Sunabori

Organization

Kagome Co., Ltd.

Division name

Innovation Division

Zip code


Address

17 Nishitomiyama, Nasushiobarashi, Tochigi, 329-2762, Japan

TEL

0287-36-2935

Email

Satoshi_Sunabori@kagome.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Chinatsu Arakawa

Organization

Kagome Co., Ltd.

Division name

Innovation Division

Zip code


Address

17 Nishitomiyama, Nasushiobarashi, Tochigi, 329-2762, Japan

TEL

0287-36-2935

Homepage URL


Email

Chinatsu_Arakawa@kagome.co.jp


Sponsor or person

Institute

Kagome Co., Ltd.

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

KSO Corporation

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

医療法人社団進興会 セラヴィ新橋クリニック(東京都)
(Medical Corporation Shinkou Kai C'est la vie Shinbashi Clinic in Tokyo)


Other administrative information

Date of disclosure of the study information

2016 Year 02 Month 14 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

2015 Year 12 Month 21 Day

Date of IRB


Anticipated trial start date

2016 Year 02 Month 14 Day

Last follow-up date

2016 Year 04 Month 16 Day

Date of closure to data entry

2016 Year 05 Month 31 Day

Date trial data considered complete

2016 Year 06 Month 10 Day

Date analysis concluded

2016 Year 06 Month 30 Day


Other

Other related information



Management information

Registered date

2016 Year 02 Month 12 Day

Last modified on

2018 Year 08 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024231


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name