UMIN-CTR Clinical Trial

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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025423