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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000019576
Receipt No. R000022633
Scientific Title The effect of mandarin orange yogurt against allergic conjunctivitis by conjunctival allergen challenge test
Date of disclosure of the study information 2015/10/30
Last modified on 2017/10/30

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Basic information
Public title The effect of mandarin orange yogurt against allergic conjunctivitis by conjunctival allergen challenge test
Acronym The effect of mandarin orange yogurt against allergic conjunctivitis
Scientific Title The effect of mandarin orange yogurt against allergic conjunctivitis by conjunctival allergen challenge test
Scientific Title:Acronym The effect of mandarin orange yogurt against allergic conjunctivitis
Region
Japan

Condition
Condition Allergic conjunctivitis
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the relaxation effect by ingestion of mandarin orange yogurt on allergic conjunctivitis by slitlamp microscopy, ocular surface thermography and inteview.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To determine the relaxation effect by ingestion of mandarin orange yogurt on allergic conjunctivitis.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Half of the randamized and blinding subujects ingest 150ml of mandarin orange yogurt 1/day for 3 weeks. Thereafter they injest 150ml of control yogurt 1/day for 3 weeks.
Interventions/Control_2 Half of the randamized and blinding subujects ingest 150ml of control yogurt 1/day for 3 weeks. Thereafter they injest 150ml of mandarin orange yogurt 1/day for 3 weeks.
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

Not applicable
Gender Male and Female
Key inclusion criteria 1)20 years old or older
2)Subjects who be obtained informed consent
3)Cedar pollen allergy
Key exclusion criteria 1)During pregnancy During lactation
2)During oral treatment in allergic diseases
3Patients who cannot be obtained informed consent
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Atsushi Shiraishi
Organization Ehime University Hospital
Division name Ophthalmology
Zip code
Address Shizukawa, Tohon-city, Ehime, Japan
TEL 089-960-5361
Email shiraia@m.ehime-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yuko Hara
Organization Ehime University Hospital
Division name Ophthalmology
Zip code
Address Shizukawa, Tohon-city, Ehime, Japan
TEL 089-960-5361
Homepage URL
Email yukoabc@m.ehime-u.ac.jp

Sponsor
Institute Department of Ophthalmology, Ehime University Hospital
Institute
Department

Funding Source
Organization Shikoku nyugyou corporation
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
2015 Year 10 Month 30 Day

Related information
URL releasing protocol
Publication of results Published

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 Main results already published
Date of protocol fixation
2015 Year 09 Month 28 Day
Date of IRB
Anticipated trial start date
2015 Year 09 Month 28 Day
Last follow-up date
2016 Year 10 Month 30 Day
Date of closure to data entry
2017 Year 01 Month 31 Day
Date trial data considered complete
2017 Year 03 Month 31 Day
Date analysis concluded
2017 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2015 Year 10 Month 30 Day
Last modified on
2017 Year 10 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022633

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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