UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019474
Receipt number R000022313
Scientific Title A randomized, double-blind, placebo-controlled, parallel-group, multi-center clinical trial to assess the effect of Bifidobacterium longum BB536 ingestion on improvement of blood hemoglobin.
Date of disclosure of the study information 2015/10/24
Last modified on 2018/06/14 19:20:34

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Basic information

Public title

A randomized, double-blind, placebo-controlled, parallel-group, multi-center clinical trial to assess the effect of Bifidobacterium longum BB536 ingestion on improvement of blood hemoglobin.

Acronym

A clinical trial to assess the effect of Bifidobacterium longum BB536 ingestion on hemoglobin improvement.

Scientific Title

A randomized, double-blind, placebo-controlled, parallel-group, multi-center clinical trial to assess the effect of Bifidobacterium longum BB536 ingestion on improvement of blood hemoglobin.

Scientific Title:Acronym

A clinical trial to assess the effect of Bifidobacterium longum BB536 ingestion on hemoglobin improvement.

Region

Japan


Condition

Condition

None(Healthy subjects)

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This study aimed to evaluate the efficacy of Bifidobacterium longum BB536 ingestion in improvement of hemoglobin value in women.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Anemia-related indcator(12 weeks after intake)

Key secondary outcomes



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

NO

Institution consideration

Institution is considered as a block.

Blocking

YES

Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Daily ingestion of 2 capsules containing Bifidobacterium longum BB536 for 12 weeks.

Interventions/Control_2

Daily ingestion of 2 placebo capsules devoid of Bifidobacterium longum BB536 for 12 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

18 years-old <=

Age-upper limit


Not applicable

Gender

Female

Key inclusion criteria

(1) Women who are more than 18 years old at the time of informed consent acquisition
(2) Subjects whose Hb levels are above 12 g/dL and less than 13 g/dL.

Key exclusion criteria

(1)Subjects who regularly uses the health foods such as supplements for the purpose of iron or folic acid supply.
(2)Subjects who have serious disease
(liver, kidney, cerebrovascular, endocrine metabolic diseases, infectious diseases that requires notification) needed to notify
(3)Subjects receiving treatment or medication for cancer, and subjects with a history of cancer.
(4)Subjects who have a history of major surgery of digestive system
(5)Subject with irritable bowel syndrome, inflammatory bowel syndrome or gastrointestinal dysfunction
(6)Subject who regularly undertakes
medication or treatment that affects bowel motion (such as: antibiotics, antiflatulents, laxatives, antidiarrheal drug) or functional food / nutraceuticals, health supplements (such as: lactic acid bacteria, bifidobacteria, oligosaccharides, dietary fiber)
(7)Subject with a history of allergy to medicine and food
(8)Subject who donated: 400ml whole blood within past 12 weeks or 200ml whole blood within past 4 weeks or plasma or platelets within past 2 weeks prior to this study
(9)Subject who is judged to be ineligible due to subject's background, physical findings, medical examination, physical and clinical examination by principal investigator or sub investigator.

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Taeko Shimoda

Organization

Nara Women's University

Division name

Department of Food and Nutrition

Zip code


Address

Kita-Uoya Nishimachi, Nara 630-8506 Japan

TEL

0742203893

Email

t-shimoda@cc.nara-wu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Taeko Shimoda

Organization

Nara Women's University

Division name

Department of Food and Nutrition

Zip code


Address

Kita-Uoya Nishimachi, Nara 630-8506 Japan

TEL

0742-20-3893

Homepage URL


Email

t-shimoda@cc.nara-wu.ac.jp


Sponsor or person

Institute

Tenshi College

Institute

Department

Personal name



Funding Source

Organization

Morinaga Milk Industry Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan


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

天使大学(北海道)、東京医療保健大学(東京都)/Tenshi College, Tokyo Healthcare University


Other administrative information

Date of disclosure of the study information

2015 Year 10 Month 24 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 09 Month 10 Day

Date of IRB


Anticipated trial start date

2015 Year 10 Month 24 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

2015 Year 10 Month 23 Day

Last modified on

2018 Year 06 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022313


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name