UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008142 |
|---|---|
| Receipt number | 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 19:00:28 |
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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
| Obstetrics 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
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
Sponsor or person
Institute
Graduate School of Medicine, Chiba University
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
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009427
