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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000022056
Receipt No. 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 2019/10/17

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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
Email 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
Email ucchi-no@med.toho-u.ac.jp

Sponsor
Institute Toho University School of medicine
Department of Pediatrics
Institute
Department

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
Email 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 No longer recruiting
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
2022 Year 08 Month 31 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
2019 Year 10 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025423

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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