UMIN-CTR Clinical Trial

Public title

A pilot study to explore the efficacy and safety of jam oral immunotherapy with hypoallergenized cow's milk for children with cow's milk allergy

Acronym

A pilot study for the effect of jam oral immunotherapy with hypoallergenized cow's milk (JMIT study)

Scientific Title

A pilot study to explore the efficacy and safety of jam oral immunotherapy with hypoallergenized cow's milk for children with cow's milk allergy

Scientific Title:Acronym

A pilot study for the effect of jam oral immunotherapy with hypoallergenized cow's milk (JMIT study)

Region

Japan

Condition

food allergy (cow's milk)

Classification by specialty

Clinical immunology

Child

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate the efficacy of oral imunotherapy with hypoallergenized cow's milk

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Phase II

Primary outcomes

The threshold change of double blind placebo controlled oral food challenge test

Key secondary outcomes

1. Effectiveness
Change of specific IgE and IgG4 level for cow's milk, casein, B-lactoglobulin

2. Safety
a. The proportion of the patients who experienced allergic reactions within 2 hours after the ingestion of the hypoallergenized milk
b. The frequency of allergic reactions within 2 hours after the ingestion of the hypoallergenized milk

3. Edibility of jam containing hypoallergenized cow's milk

4. QOL assessment by the parents and of the parents

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Slow oral immunotherapy with hypoallergenized cow's milk for 6 months

Interventions/Control_2

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

1

years-old

<=

Age-upper limit

12

years-old

>

Gender

Male and Female

Key inclusion criteria

1. Patients with cow's milk allergy
2. Patients who failed to increase the threshold through conventional slow oral immunotherapy with cow's milk continued for more than six months
3. Patients whose cow's milk-specific IgE level was greater than 15 UA/ml within 8 weeks before registration
4. Patients diagnosed as cow's milk allergy by double blind placebo controlled food challenge test
5. Patients who can keep complete elimination of cow's milk from their diet
6. Patients whose family are cooperative enough to adhere to the protocol of this study

Key exclusion criteria

1. Patients with non-immediate reaction to cow's milk
2. Patients with uncontrolled asthma, atopic dermatitis or urticaria
3. Patients with pineapple or soy allergy
4. Patients who have treatment history or plan with omalizumab
5. Patients who were undergoing oral immunotherapy of build-up phase for other food antigen

Target sample size

10

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, 157-8535 Japan

TEL

03-3416-0181

Email

ohya-y@ncchd.go.jp

Name of contact person

1st name
Middle name
Last name	Miyuki Hashimoto

Organization

National Center for Child Health and Development

Division name

Division of Allergy

Zip code

Address

2-10-1 Okura Setagaya-ku Tokyo, 157-8535 Japan

TEL

03-3416-0181

Homepage URL

Email

hashimoto-my@ncchd.go.jp

Institute

National Center for Child Health and Development

Institute

Department

Personal name

Organization

Grant from the National Center for Child Health and Development

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Co-sponsor

Sagami Women's Junior College Department of Food and Nutrition Science

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

Date of disclosure of the study information

2015

Year

07

Month

24

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2015

Year

03

Month

03

Day

Date of IRB

Anticipated trial start date

2015

Year

05

Month

19

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2015

Year

07

Month

21

Day

Last modified on

2017

Year

01

Month

25

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021272