UMIN-CTR Clinical Trial

Basic information
Public title	A verification study of anemia improvement effect of the food containing lactic acid bacteria for females who have mild anemia symptom
Acronym	A verification study of anemia improvement effect of the food containing lactic acid bacteria
Scientific Title	A verification study of anemia improvement effect of the food containing lactic acid bacteria for females who have mild anemia symptom
Scientific Title:Acronym	A verification study of anemia improvement effect of the food containing lactic acid bacteria
Region	Japan

Condition
Condition	No applicable
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To verify the anemia improvement effect for the female who have mild anemia symptom by 8 weeks consumption of the food containing lactic acid bacteria.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Hemoglobin concentration
Key secondary outcomes	Mean Corpuscular Volume (MCV) Reticlocyte count Serum ferritin concentration Total iron binding capacity(TIBC) Red blood cell Mean Corpuscular hemoglobin(MCH) Mean Corpuscular hemoglobin concentration (MCHV) Hematocrit Serum iron concentration Folic acid concentration Questionnaire of anemia subjective symptom

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
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	Consume two tablets of test food a day for eight weeks. Visit the clinic four weeks and eight weeks after starting consumption of the test food, then receive blood test and answer the questionnaire.
Interventions/Control_2	Consume two tablets of control food a day for eight weeks. Visit the clinic four weeks and eight weeks after starting consumption of the test food, then receive blood test and answer the questionnaire.
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	59 years-old >=
Gender	Female
Key inclusion criteria	(1) Healthy females aged 20 to 59 years old. (2) Subjects who showed under 12.0g/dL of blood hemoglobin concentration and who are distinguished as mild anemia. (3) Subjects who show understanding of the study procedures and agreement with participating the study by written informed consent prior to the study.
Key exclusion criteria	(1)Subjects who receive medical treatment of anemia. (2)Subjects who are dysmenorrhea. (3)Subjects who are after menopause. (4)Subjects who have an excessive unbalanced diet. (5)Subjects who have regularly used medicine, quasi-drugs, supplement and/or health food those concerned have an influence for the test, during 3 months before starting consumption of the test food. (6) Subjects who conduct excess diet control and weight control, and/or who have irregular meal customs (7)Subjects who are pregnant (including the possibility of pregnancy) or are lactating. (8)Subjects who have severe past and/or current medical history in heart, liver, kidney and/or digestive organs. (9) Subjects who are heavy drinkers of alcohol. (10) Subjects who have allergy to medicine and/or food. (11) Subjects who are participating, who have participated within 4 weeks and/or who plan to participate after informed consent of this test, in clinical test of other medicine or health food. (12) Subjects who are lactose intolerance. (13) Subjects who donated over 200mL blood and/or blood components within a month to the current study. (14) Subjects who donated over 400mL blood within the last 4 months to the current study. (15) Females who will be collected over 800mL blood and/or blood components when, the sampling amounts within the last 12 months are adding to the planned sampling amounts of this study. (16) Others they have been determined ineligible by principal investigator or sub-investigator.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Suguru Middle name Last name Fujiwara
Organization	CPCC Company Limited
Division name	Clinical Research Planning Department
Zip code	101-0047
Address	4F Chusin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN
TEL	03-5297-3112
Email	cpcc-contact@cpcc.co.jp

Public contact
Name of contact person	1st name Makoto Middle name Last name Ichinohe
Organization	CPCC Company Limited
Division name	Planning & Sales Department
Zip code	101-0047
Address	4F Chusin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN
TEL	03-5297-3112
Homepage URL
Email	cpcc-contact@cpcc.co.jp

Sponsor
Institute	CPCC Company Limited
Institute
Department

Funding Source
Organization	ICHIBIKI 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	Institutional review board of Chiyoda Paramedical Care Clinic
Address	2F Chusin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN
Tel	03-5297-5548
Email	IRB@cpcc.co.jp

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	2019 Year 09 Month 21 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	20
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	2018 Year 07 Month 08 Day
Date of IRB	2018 Year 07 Month 05 Day
Anticipated trial start date	2018 Year 08 Month 21 Day
Last follow-up date	2019 Year 10 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 08 Month 21 Day
Last modified on	2019 Year 11 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038594