UMIN-CTR Clinical Trial

Public title

Verification of the prevention effect of daily high-dose Japanese cedar pollen peptide-containing rice on onset from non-onset of Japanese cedar pollinosis(Study3)

Acronym

Verification of the prevention effect of daily high-dose Japanese cedar pollen peptide-containing rice on onset from non-onset of Japanese cedar pollinosis

Scientific Title

Verification of the prevention effect of daily high-dose Japanese cedar pollen peptide-containing rice on onset from non-onset of Japanese cedar pollinosis(Study3)

Scientific Title:Acronym

Verification of the prevention effect of daily high-dose Japanese cedar pollen peptide-containing rice on onset from non-onset of Japanese cedar pollinosis

Region

Japan

Condition

Japanese cedar pollinosis

Classification by specialty

Clinical immunology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Verification of the prevention effect of daily high-dose Japanese cedar pollen peptide-containing rice on onset from non-onset of Japanese cedar pollinosis

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Phase II

Primary outcomes

Japanese cedar pollen-specific T cell proliferative response at 0, 4, 8 weeks after the start of ingestion

Key secondary outcomes

1)serum Japanese cedar pollen-specific IgE antibody level at 0, 4, 8 weeks after the start of ingestion
2)adverse events from the start to the end of ingestion

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

YES

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

1)Japanese cedar pollen allergy relief rice 80g intake group (allergy rerief rice 80g once a day, for 8 weeks, 7cases)

Interventions/Control_2

2)the placebo group (pracebo rice 80g once a day, for 8 weeks, 3 cases)

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

20

years-old

<=

Age-upper limit

70

years-old

>

Gender

Male and Female

Key inclusion criteria

1)those who have no symptoms related allergic rhinitis consistent with the cedar pollen season
2)those whose Japanese cedar pollen allergen-specific IgE antibody titer show class the 2 or 3 (measured by AlaSTAT 3g method)
3)those whose Japanese ceder pollen-specific T cell proliferative response show positive
4)those who live or work in Osaka prefecture and consented to research participation by the document from the person obtained
5)those who can comply with not to transfer the test product to a third party

Key exclusion criteria

1)those whom Principal Investigator or the sharing researchers have determined inappropriate
2)those who suffer from rice allergy or have a history of rice allergy
3)those who have received immunotherapy for cedar pollen, or have the schedule
4)those who suffer from some serious disease with disease activity, therefore, are judged unsuitable for enrolement by the clinician
5)those who are or planning to become pregnant or in the process of breast-feeding during the clinical reseach
6)those who are participating in other clinical research

Target sample size

10

Name of lead principal investigator

1st name
Middle name
Last name	Shoji Hashimoto

Organization

Osaka Habikino Medical Center

Division name

Department of Clinical Research & Development

Zip code

Address

3-7-1 Habikino Habikino city Osaka

TEL

072-957-2121

Email

hashisyo@ra.opho.jp

Name of contact person

1st name
Middle name
Last name	Shoji Hashimoto

Organization

Osaka Habikino Medical Center

Division name

Department of Clinical Research & Development

Zip code

Address

3-7-1 Habikino Habikino city Osaka

TEL

072-957-2121

Homepage URL

Email

hashisyo@ra.opho.jp

Institute

Osaka Habikino Medical Center

Institute

Department

Personal name

Organization

Osaka Habikino Medical Center

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

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

(地独)大阪はびきの医療センター

Date of disclosure of the study information

2018

Year

12

Month

04

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

No longer recruiting

Date of protocol fixation

2018

Year

09

Month

13

Day

Date of IRB

Anticipated trial start date

2018

Year

11

Month

27

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2018

Year

12

Month

03

Day

Last modified on

2018

Year

12

Month

03

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040025