UMIN-CTR Clinical Trial

Public title

Prevention of egg allergy in infants with atopic dermatitis.

Acronym

Prevention of egg allergy with tiny amount intake.

Scientific Title

Prevention of egg allergy in infants with atopic dermatitis.

Scientific Title:Acronym

Prevention of egg allergy with tiny amount intake.

Region

Japan

Condition

food allergy

Classification by specialty

Clinical immunology	Pediatrics	Dermatology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To investigate whether early introduction of food protein in complementary food at six months old can reduce onset of food allergy in infants with atopic dermatitis.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase III

Primary outcomes

Negative diagnostic rate of food challenge test with hen's egg at one year old.

Key secondary outcomes

Measurement of the following bio markers of the subjects at their entry, nine months old and one year old:
- antigen-specific antibody IgG1, IgG4, IgA and IgE in serum.
- serum TARC.
- antigen-specific antibody IgG1, IgG4, IgA and IgE in saliva.

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is considered as a block.

Blocking

YES

Concealment

Central registration

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Subjects are fed with 50 mg of egg powder daily starting at six months old. After three months, amount of egg powder is increased to 250mg. During the intervention, subjects are not allowed to eat any other food that contains egg.

Interventions/Control_2

Subjects are fed with placebo (pumpkin) powder daily starting at six months old. During the intervention, subjects are not allowed to eat any other food that contains egg.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

4

months-old

<=

Age-upper limit

6

months-old

>

Gender

Male and Female

Key inclusion criteria

Infants aged four to five months old who were diagnosed with atopic dermatitis by a physician.

Key exclusion criteria

(1) Infants born before 37 weeks of gestation.
(2) Infants who have already being fed with egg.
(3) Infants with a history of immediate type allergic reaction to egg.
(4) Infants with possible atypical food allergy other than immediate type food allergy.
(5) Infants with severe complications.

Target sample size

200

Name of lead principal investigator

1st name
Middle name
Last name	Yukihiro Ohya

Organization

National Center for Child Health and Development

Division name

Division of Allergy

Zip code

Address

2-10-1 Okura Setagaya-ku Tokyo

TEL

0334160181

Email

ohya-y@ncchd.go.jp

Name of contact person

1st name
Middle name
Last name	Shigenori Kabashima, Osamu Natsume

Organization

National Center for Child Health and Development

Division name

Division of allergy

Zip code

Address

2-10-1 Okura Setagaya-ku Tokyo

TEL

0334160181

Homepage URL

Email

natsume-o@ncchd.go.jp

Institute

National Center for Child Health and Development

Institute

Department

Personal name

Organization

Ministry of Health, Labour and Welfare scientific research

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

国立成育医療研究センター

Date of disclosure of the study information

2012

Year

08

Month

10

Day

URL releasing protocol

http://www.ncchd.go.jp/en/hospital/about/section/medical_subspecialties/pdf/PETITprotocol.pdf

Publication of results

Published

URL related to results and publications

http://www.sciencedirect.com/science/article/pii/S0140673616314180?via%3Dihub

Number of participants that the trial has enrolled

Results

Lancet. 2017 Jan 21;389(10066):276-286. doi: 10.1016/S0140-6736(16)31418-0.

Between Sept 18, 2012, and Feb 13, 2015, we randomly allocated 147 participants (73 [50%] to the egg group and 74 [50%] to the placebo group). This trial was terminated on the basis of the results of the scheduled interim analysis of 100 participants, which showed a significant difference between the two groups (four [9%] of 47 participants had an egg allergy in the egg group vs 18 [38%] of 47 in the placebo group; risk ratio 0.222 [95% CI 0.081-0.607]; p=0.0012). In the primary analysis population, five (8%) of 60 participants had an egg allergy in the egg group compared with 23 (38%) of 61 in the placebo group (risk ratio 0.221 [0.090-0.543]; p=0.0001). The only difference in adverse events between groups was admissions to hospital (six [10%] of 60 in the egg group vs none in the placebo group; p=0.022). 19 acute events occurred in nine (15%) participants in the egg group versus 14 events in 11 (18%) participants in the placebo group after intake of the trial powder.

conclusion
Introduction of heated egg in a stepwise manner along with aggressive eczema treatment is a safe and efficacious way to prevent egg allergy in high-risk infants. In this study, we developed a practical approach to overcome the second wave of the allergic epidemic caused by food allergy.

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

Recruitment status

Terminated

Date of protocol fixation

2012

Year

03

Month

30

Day

Date of IRB

Anticipated trial start date

2012

Year

09

Month

01

Day

Last follow-up date

2015

Year

03

Month

30

Day

Date of closure to data entry

2015

Year

04

Month

18

Day

Date trial data considered complete

2015

Year

05

Month

15

Day

Date analysis concluded

2015

Year

07

Month

21

Day

Other related information

We revised the registration at 26 June 2014, for revealing the timing of interventions and data samplings of secondary outcome from "start of the study, after 3 months, at the end" to "at their entry (4 to 6 months of age), nine months old and one year old".
Also the method of randomization was revised at 26 June 2014 because it was incorrectly translated in Stratification and Blocking.
The institution consideration was incorrect until 2015 July . So we revised it at 3rd August 2015.

Registered date

2012

Year

08

Month

10

Day

Last modified on

2017

Year

11

Month

15

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010190