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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008142
Receipt No. R000009427
Scientific Title Effect of the prebiotics taken by pregnant and lactating women on the immunoactive substance in the breast milk and bowel movement
Date of disclosure of the study information 2012/07/01
Last modified on 2012/12/16

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Basic information
Public title Effect of the prebiotics taken by pregnant and lactating women on the immunoactive substance in the breast milk and bowel movement
Acronym The effect of the prebiotics on mothers' milk
Scientific Title Effect of the prebiotics taken by pregnant and lactating women on the immunoactive substance in the breast milk and bowel movement
Scientific Title:Acronym The effect of the prebiotics on mothers' milk
Region
Japan

Condition
Condition pregnant woman
Classification by specialty
Obsterics and gynecology Pediatrics
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To check the prebiotics medication to a pregnant woman influence the immunoactive agents in breastmilk, bowel movement of pregnant woman, and the development of allergic diseases of children.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes cytokines, IgA and sCD14 in breastmilk
Key secondary outcomes 1. Specific and non specific IgE in mother's blood and umbilical cord blood.
2. Profile of gene expression in white blood cells in breastmilk
3. Changes in bowel habit
4. Changes in intestinal flora of mothers
5. Existence of allergic diseases of chilren at the age of six month

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 prebiotics
Interventions/Control_2 placebo
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

Not applicable
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria normal pregnant woman
Key exclusion criteria 1. The pregnant woman who need whole body control for toxemia of pregnancy or other diseases during pregnancy progress.
2. The pregnant woman who were judged to be unsuitable from efficacy and safety by doctor.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naoki Shimojo
Organization Graduate School of Medicine, Chiba University
Division name Pediatrics
Zip code
Address 1-8-1 Inohana Chuou-ku Chiba city
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Naoki Shimojo
Organization Graduate School of Medicine, Chiba University
Division name Pediatrics
Zip code
Address
TEL 043-226-5364
Homepage URL
Email

Sponsor
Institute Graduate School of Medicine, Chiba University
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
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 増田産婦人科(千葉県)

Other administrative information
Date of disclosure of the study information
2012 Year 07 Month 01 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
2009 Year 08 Month 26 Day
Date of IRB
Anticipated trial start date
2009 Year 09 Month 01 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
2012 Year 06 Month 11 Day
Last modified on
2012 Year 12 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009427

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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