UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022056 |
|---|---|
| Receipt number | R000025423 |
| Scientific Title | Effects of probiotics to women during late pregnancy and lactation in the prevention of allergy in infants |
| Date of disclosure of the study information | 2016/04/25 |
| Last modified on | 2021/04/29 17:53:03 |
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Basic information
Public title
Effects of probiotics to women during late pregnancy and lactation in the prevention of allergy in infants
Acronym
Effects of probiotics in the prevention of allergy in infants
Scientific Title
Effects of probiotics to women during late pregnancy and lactation in the prevention of allergy in infants
Scientific Title:Acronym
Effects of probiotics in the prevention of allergy in infants
Region
| Japan |
Condition
Condition
Atopic dermatitis
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
By administering the probiotics to mother during late pregnancy and lactation , eczema is suppressed, to consider if you can prevent percutaneous sensitization in infants.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
infant intestinal flora
number of bacteria
species of bacteria
allergic diseases until 3y
intestinal flora of pregnant women
human milk
cytokine in cord blood
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Pregnant women are given yogurt until parturition.
Interventions/Control_2
Pregnant women are given yogurt until lactation.
Interventions/Control_3
Lactation women are given yogurt after parturition.
Interventions/Control_4
Control group is not received yogurt during the same period of their lactation.
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
| 45 | years-old | >= |
Gender
Female
Key inclusion criteria
Performs research described pregnancy 26-27 weeks, pregnant women consent was obtained.
Key exclusion criteria
Toxemia of pregnancy
Gestational diabetes mellitus
milk allergy
Hypertension
underlying diseases
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Misa |
| Middle name | |
| Last name | Watanabe |
Organization
Toho University School of medicine
Division name
Department of Pediatrics
Zip code
143-8541
Address
6-11-1,Omori-Nishi,Ota-ku,Tokyo
TEL
03-3762-4151
misa-watanabe@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | Yumiko |
| Middle name | |
| Last name | Komine |
Organization
Toho University School of medicine
Division name
Department of Pediatrics
Zip code
143-8541
Address
6-11-1
TEL
70337624151
Homepage URL
ucchi-no@med.toho-u.ac.jp
Sponsor or person
Institute
Toho University School of medicine
Department of Pediatrics
Institute
Department
Personal name
Funding Source
Organization
Takanashi Milk Products Co.,Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
University of Turuku
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Toho University School of medicine
Address
6-11-1,Omori-Nishi,Ota-ku,Tokyo
Tel
03-3762-4151
med.rinri@ext.toho-u.ac.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
東邦大学医療センター大森病院（東京都）、内野産婦人科（東京都）
Toho University School of medicine Department of Pediatrics（Tokyo）
Uchino Obstetrics and Gynecology Pediatrics（Tokyo)
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 04 | Month | 25 | 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
0
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 | 04 | Month | 25 | Day |
Date of IRB
| 2015 | Year | 12 | Month | 11 | Day |
Anticipated trial start date
| 2015 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 04 | Month | 29 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 04 | Month | 25 | Day |
Last modified on
| 2021 | Year | 04 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025423
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
