UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043525
Receipt number R000049697
Scientific Title A pilot study to identify the prevention of food allergy by administering synbiotics to pregnant women and newborns
Date of disclosure of the study information 2021/03/05
Last modified on 2021/03/04 21:30:45

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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 or person

Institute

National Hospital Organization Sagamihara National Hospital

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049697


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name