UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024700
Receipt number R000028419
Scientific Title Verification of suppressing effects of Japanese cedar pollen peptide-containing rice on symptoms and IgE associated with Japanese cedar pollinosis (Study 2)
Date of disclosure of the study information 2016/11/04
Last modified on 2018/12/03 14:38:47

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Verification of suppressing effects of Japanese cedar pollen peptide-containing rice on symptoms and IgE associated with Japanese cedar pollinosis (Study 2)

Acronym

Verification of suppressing effect of Japanese cedar pollen peptide-containing rice on Japanese cedar pollen-specific IgE

Scientific Title

Verification of suppressing effects of Japanese cedar pollen peptide-containing rice on symptoms and IgE associated with Japanese cedar pollinosis (Study 2)

Scientific Title:Acronym

Verification of suppressing effect of Japanese cedar pollen peptide-containing rice on Japanese cedar pollen-specific IgE

Region

Japan


Condition

Condition

Japanese cedar pollinosis

Classification by specialty

Clinical immunology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Verification of suppressing effect of Japanese cedar pollen peptide-containing rice on Japanese cedar pollen-specific IgE

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

serum Japanese cedar pollen-specific IgE antibody level at 0, 12, 24, 36 48, 60, 72, 84, 96weeks after the stat of ingestion

Key secondary outcomes

1)Japanese cedar pollen-specific T cell proliferative response at at 0, 12, 24, 36 48, 60, 72, 84, 96weeks after the stat of ingestion
2)Adverse events from the start to the end of ingestion


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

NO

Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Japanese cedar pollen allergy relief rice 5g intake group (allergy rerief rice 5g plus pracebo rice 45g once a day, for 96 weeks, 10 cases)

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

70 years-old >

Gender

Male and Female

Key inclusion criteria

1)those who have presented with symptoms related allergic rhinitis such as sneezing, nasal discharge, obstruction and eye itching for at least 2continuous years, consistent with the cedar pollen season
2)those whose Japanese cedar pollen allergen-specific IgE antibody titer show class the 2 or more (measured by AlaSTAT 3g method)
3)those whose Japanese cypress pollen-specific IgE antibody titer show the class 4 or less (AlaSTAT 3g)
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 whose pets (dogs, cats) and house dust and mite-specific IgE antibody titers show the class of 5 or more, ond who are breeding a pet.
4)those whose house dust and mite-specific IgE antibody titer, swow higher than the cedar pollen-specific IgE antibody titers
5)those who have received immunotherapy for cedar pollen, or have the schedule
6)those who suffer from some serious disease with disease activity, therefore, are judged unsuitable for enrolement by the clinician
7)those who are or planning to become pregnant or in the process of breast-feeding during the clinical reseach
8)those who are participating in other clinical research

Target sample size

10


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shoji Hashimoto

Organization

Osaka Habikino Medical Center

Division name

Clinical Reseach Center

Zip code


Address

3-7-1 Habikino Habikino city Osaka

TEL

072-957-2121

Email

hashisyo@ra.opho.jp


Public contact

Name of contact person

1st name
Middle name
Last name Shoji Hashimoto

Organization

Osaka Habikino Medical Center

Division name

Clinical Reseach Center

Zip code


Address

3-7-1 Habikino Habikino city Osaka

TEL

072-957-2121

Homepage URL


Email

hashisyo@ra.opho.jp


Sponsor or person

Institute

Osaka Habikino Medical Center

Institute

Department

Personal name



Funding Source

Organization

Osaka Habikino Medical Center

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

Department of Clinical Application of Biologics, Osaka University Graduate School of Medicine

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

(地独)大阪はびきの医療センター


Other administrative information

Date of disclosure of the study information

2016 Year 11 Month 04 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

No longer recruiting

Date of protocol fixation

2016 Year 09 Month 12 Day

Date of IRB


Anticipated trial start date

2016 Year 09 Month 16 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

2016 Year 11 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=R000028419


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name