UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030611
Receipt number R000034959
Scientific Title Examination of influence on the skin prick test by intake of test food for persons with cedar pollen allergy
Date of disclosure of the study information 2018/01/03
Last modified on 2018/03/14 13:12:49

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Basic information

Public title

Examination of influence on the skin prick test by intake of test food for persons with cedar pollen allergy

Acronym

Examination of influence on the skin prick test by intake of test food for persons with cedar pollen allergy

Scientific Title

Examination of influence on the skin prick test by intake of test food for persons with cedar pollen allergy

Scientific Title:Acronym

Examination of influence on the skin prick test by intake of test food for persons with cedar pollen allergy

Region

Japan


Condition

Condition

cedar pollen allergy

Classification by specialty

Clinical immunology Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examination of influence on the skin prick test by intake of test food for persons with cedar pollen allergy.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Skin prick test (positive rate, rash diameter, redness diameter), questionnaire

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Self control

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Intake of test food for 4 weeks

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



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit

64 years-old >=

Gender

Male and Female

Key inclusion criteria

(1) Males and females from 20 to 64 years of age
(2) Subjects who are aware of cedar pollen allergy
(3) Subjects with positive specific IgE test and skin prick test against cedar antibodies

Key exclusion criteria

(1) Subjects that regularly consume enhanced test food
(2) Subjects that regularly consume dietary supplements which may influence immune function
(3) Subjects with history of the allergic disease or anaphylactic shock (except for hay fever)
(4) Subjects undergoing medical treatment which may influence the outcome of the study
(5) Subjects with skin disease or a tattoo on the arm
(6) Night and day shift worker or manual laborer
(7) Subjects with intensive physical activity
(8) Subjects with poor adherence to the measurement procedures
(9) Subjects with severe diseases (e.g., diabetes, liver disease, kidney disease, or heart disease) and diseases that may affect the adrenal cortical hormone secretion
(10) Subjects potentially allergic to contents in test food
(11) Subjects who are judged inappropriate for the study according to the results of screening tests
(12) Subjects who intend to become pregnant during the study period or being pregnant or lactating
(13) Subjects who have participated in other clinical studies within one month from obtaining informed consent or intend to participate in other clinical studies after obtaining informed consent
(14) Subjects who are judged inappropriate for the study according to the results of lifestyle questionnaire
(15) Subjects who are judged inappropriate for the study by the physician

Target sample size

10


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Akihito Tomonaga

Organization

Tana orthopedic surgery

Division name

Orthopedic surgery

Zip code


Address

15-7, Tana-cho, Aoba-ku, Yokohama-city, Kanagawa

TEL

045-989-2225

Email

soyaku@kaiseikai-net.or.jp


Public contact

Name of contact person

1st name
Middle name
Last name Takashi Nakagawa

Organization

TTC Co., Ltd.

Division name

Clinical Research Planning Department

Zip code


Address

Seibu Shinkin Bank Ebisu Bldg., 1-20-2, Ebisunishi, Shibuya-ku, Tokyo

TEL

03-5459-5329

Homepage URL


Email

t.nakagawa@ttc-tokyo.co.jp


Sponsor or person

Institute

TTC Co., Ltd

Institute

Department

Personal name



Funding Source

Organization

KYOWA Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

2018 Year 01 Month 03 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

Completed

Date of protocol fixation

2017 Year 12 Month 19 Day

Date of IRB


Anticipated trial start date

2018 Year 01 Month 04 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2017 Year 12 Month 28 Day

Last modified on

2018 Year 03 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034959


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name