UMIN-CTR Clinical Trial

Basic information
Public title	A pilot study to identify the prevention of food allergy by administering synbiotics to pregnant women and newborns
Acronym	A study to identify the prevention of food allergy by the administration of synbiotics
Scientific Title	A pilot study to identify the prevention of food allergy by administering synbiotics to pregnant women and newborns
Scientific Title:Acronym	A study to identify the prevention of food allergy by the administration of synbiotics
Region	Japan

Condition
Condition	food allergy
Classification by specialty	Pediatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the efficacy of synbiotics on preventing the development of food allergy in a population at high risk of developing a food allergy.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Differences and changes in the type and diversity of intestinal microflora in children at 4 months of age
Key secondary outcomes	(1)Presence of immediate food allergy at 1 year of age (2)Changes in short-chain fatty acids in the blood (3)Differences and changes in the types and diversity of breast milk and skin flora (4)Sensitization to food allergen at 1 year of age (5)Presence and severity of eczema at 1 year of age (6)Stratify results affected by mode of delivery, method of child nutrition, and child skin condition

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	In intervention group A, pregnant women consume synbiotics (Lactobacillus rhamnosus GG, Bifidobacterium bifidum, and 1-kestose) daily from 34-35 weeks gestation until postpartum day 5, and newborns from day 0 to day 5.
Interventions/Control_2	In intervention group B, newborns will take synbiotics (Lactobacillus rhamnosus GG, Bifidobacterium bifidum, 1-kestose) from day 0 to day 5.
Interventions/Control_3	In a non-intervention group, participants will not take synbiotics
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	Male and Female
Key inclusion criteria	1. Pregnant women at 34 to 35 weeks gestation 2. Either the pregnant woman or her partner has one or more of the following allergic diseases: atopic dermatitis, bronchial asthma, food allergy, allergic rhinitis, allergic conjunctivitis 3. A child born on day 0 to a pregnant woman who meets the above criteria 1 and 2.
Key exclusion criteria	1.The pregnant woman who has an obvious underlying medical condition 2.Twins 3.Premature birth or low birth weight infant 4.Severe neonatal asphyxia (Apgar score <4) 5.Children deemed by their doctor to be unsuitable for participation in the study
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Noriyuki Middle name Last name Yanagida
Organization	National Hospital Organization Sagamihara National Hospital
Division name	Department of pediatrics
Zip code	252-0392
Address	18-1, Sakuradai, Minamiku, Sagamihara City, Kanagawa, Japan
TEL	042-742-8311
Email	yana@foodallergy.jp

Public contact
Name of contact person	1st name Yoko Middle name Last name Miura
Organization	National Hospital Organization Sagamihara National Hospital
Division name	Department of pediatrics
Zip code	252-0392
Address	18-1, Sakuradai, Minamiku, Sagamihara City, Kanagawa, Japan
TEL	042-742-8311
Homepage URL
Email	yoko6299@gmail.com

Sponsor
Institute	National Hospital Organization Sagamihara National Hospital
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	Technical Research Laboratory Takanashi MilkProducts Co. Ltd. Japan
Name of secondary funder(s)

IRB Contact (For public release)
Organization	National Hospital Organization Sagamihara National Hospital
Address	18-1, Sakuradai, Minamiku, Sagamihara City, Kanagawa, Japan, 252-0392
Tel	042-742-8311
Email	222-rinri@mail.hosp.go.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

Other administrative information
Date of disclosure of the study information	2021 Year 03 Month 05 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	Open public recruiting
Date of protocol fixation	2020 Year 12 Month 10 Day
Date of IRB	2020 Year 12 Month 18 Day
Anticipated trial start date	2021 Year 02 Month 26 Day
Last follow-up date	2024 Year 03 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	2021 Year 03 Month 04 Day
Last modified on	2021 Year 03 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049697