UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015338
Receipt number R000017837
Scientific Title Effects of a lactic acid bacteria beverage on bowel movement and intestinal microflora: double blind, placebo-controlled study
Date of disclosure of the study information 2014/10/03
Last modified on 2015/04/06 13:09:40

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Basic information

Public title

Effects of a lactic acid bacteria beverage on bowel movement and intestinal microflora: double blind, placebo-controlled study

Acronym

Effects of a lactic acid bacteria beverage on bowel movement and intestinal microflora

Scientific Title

Effects of a lactic acid bacteria beverage on bowel movement and intestinal microflora: double blind, placebo-controlled study

Scientific Title:Acronym

Effects of a lactic acid bacteria beverage on bowel movement and intestinal microflora

Region

Japan


Condition

Condition

Subjects with a tendency for constipation

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Effects of a lactic acid bacteria beverage on bowel movement and intestinal microflora of adults with a tendency for constipation.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Defecation frequency, defecation days, intestinal microflora

Key secondary outcomes

Stool output, fecal condition, quantitative analysis of intestinal microflora (total anaerobes, Bifidobacterium, Clostridium perfringens), fecal water content, fecal pH


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Ingestion of lactic acid bacteria beverage containing Lactobacillus plantarum LP14 for 2 weeks

Interventions/Control_2

Ingestion of placebo beverage without Lactobacillus plantarum LP14 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

64 years-old >=

Gender

Male and Female

Key inclusion criteria

(1) Males and females from 20 to 64 years of age
(2) Subjects with a tendency for constipation at three to five times of defecation per week

Key exclusion criteria

(1) Subjects regularly using drugs (constipation drugs, intestinal drugs, etc.)
, health foods (senna tea, kefir, etc.), or foods for specified health use (indigestible dextrin, chitosan, oligosaccharides, etc.)
(2) Subjects having a large amount of foods such as lactic acid bacteria beverage, food containing lactic acid bacteria (yogurt, kimchi, pickles, sushi fermented with fish and vegetables, etc.), lactic acid bacteria preparation, dietary fiber enriched food, and oligosaccharides more than three times a week
(3) Subjects visiting the hospital for diseases related bowel movements and using drugs, or using commercial laxative
(4) Subjects currently undergoing treatment with digestive diseases that affect the study or having a surgical history of digestive system (except appendicectomy)
(5) Subjects having diseases (irritable enteritis, ulcerative colitis, etc.) affecting bowel movement or a history of these diseases
(6) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire
(7) Subjects judged as unsuitable for this study based on the results of clinical examination or cardiopulmonary abnormality
(8) Subjects having possibilities for emerging allergy related to the study
(9) Subjects having a disease requiring regular medication or a history of serious diseases for which medication was required
(10) Subjects who have participated in other clinical studies
(11) Subjects who intend to become pregnant or lactating
(12) Subjects judged as unsuitable for the study by physician for other reasons

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Manabu Shizume

Organization

Shizume Kinen Clinic

Division name

internal medicine

Zip code


Address

2-16-7 Yoyogi, Shibuya-ku, Tokyo

TEL

03-3299-3591

Email

shizumechiken@yahoo.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Mika Watanabe

Organization

TTC Co., Ltd.

Division name

Clinical Research Planning Department

Zip code


Address

1-20-2 Ebisunishi, Shibuya-ku, Tokyo

TEL

03-5459-5329

Homepage URL


Email

m.watanabe@ttc-tokyo.co.jp


Sponsor or person

Institute

TTC Co., Ltd.

Institute

Department

Personal name



Funding Source

Organization

Nissin Foods Holdings 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

2014 Year 10 Month 03 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

2014 Year 08 Month 01 Day

Date of IRB


Anticipated trial start date

2014 Year 10 Month 02 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 10 Month 03 Day

Last modified on

2015 Year 04 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017837


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name