UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020420 |
|---|---|
| Receipt number | R000023584 |
| Scientific Title | Study of additive effect of citrus juice fermented with lactic bacteria to sublingual immunotherapy for Japanese cedar pollinosis (Randomized placebo controlled double blind clinical study) |
| Date of disclosure of the study information | 2016/01/03 |
| Last modified on | 2018/07/05 05:25:18 |
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Basic information
Public title
Study of additive effect of citrus juice fermented with lactic bacteria to sublingual immunotherapy for Japanese cedar pollinosis (Randomized placebo controlled double blind clinical study)
Acronym
Study of additive effect of citrus juice fermented with lactic bacteria to sublingual immunotherapy
Scientific Title
Study of additive effect of citrus juice fermented with lactic bacteria to sublingual immunotherapy for Japanese cedar pollinosis (Randomized placebo controlled double blind clinical study)
Scientific Title:Acronym
Study of additive effect of citrus juice fermented with lactic bacteria to sublingual immunotherapy
Region
| Japan |
Condition
Condition
Japanese cedar pollinosis
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine an additive effect of the citrous juice fermented with lactic bacteria (YIT0132) to sublingual immunotherapy for Japanese cedar pollinosis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of the total nosal symptom medication score converted from a nasal allergy diary in peak of cedar pollen scattering
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
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
Taking 125ml of citrus juice fermented with lactic bacteria (YIT0132) every day for 3 month around cedar pollen scattering period.
Interventions/Control_2
Taking 125ml of placebo every day for 3 month around cedar pollen scattering period.
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with Japanese cedar pollinosis who is being treated with sublingual immunotherapy
Key exclusion criteria
1) Allergy to the intervention drink or citrus juice
2) Diabetes mellitus (HbA1c more than 6.0)
3) Pregnant women and those at risk of pregnancy
4) Women who are planning pregnancy
5) Lactating woman
6) Patients treated with anti-allergic drugs within 2 week of screening
7) The patients who the doctor judged inappropriate for the study
8) Severe asthma
9) Malignant disease or immune disorder
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshitaka Okamoto |
Organization
Chiba University Graduate School
Division name
Department of Otorhinolaryngology
Zip code
Address
1-8-1 Inohana,Chuo-ku Chiba 260-8677
TEL
043-222-7171
yokamoto@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Syuji Yonekura |
Organization
Chiba University Graduate School
Division name
Department of Otorhinolaryngology
Zip code
Address
1-8-1 Inohana,Chuo-ku Chiba 260-8677
TEL
043-222-7171
Homepage URL
syonekura@faculty.chiba-u.jp
Sponsor or person
Institute
Department of Otorhinolaryngology in Ciba University Graduate School
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2016 | 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
| 2015 | Year | 12 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2016 | 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
| 2016 | Year | 01 | Month | 03 | Day |
Last modified on
| 2018 | Year | 07 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023584
