UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021215
Receipt number R000024463
Scientific Title A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Comparison Study on Anti-Allergic Effects of Continuous Ingestion of Lactococcus lactis subsp. cremoris YRC3780
Date of disclosure of the study information 2016/02/26
Last modified on 2017/06/15 14:11:05

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Basic information

Public title

A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Comparison Study on Anti-Allergic Effects of Continuous Ingestion of Lactococcus lactis subsp. cremoris YRC3780

Acronym

Anti-Allergic Effects of Continuous Ingestion of Lactococcus lactis subsp. cremoris YRC3780

Scientific Title

A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Comparison Study on Anti-Allergic Effects of Continuous Ingestion of Lactococcus lactis subsp. cremoris YRC3780

Scientific Title:Acronym

Anti-Allergic Effects of Continuous Ingestion of Lactococcus lactis subsp. cremoris YRC3780

Region

Japan


Condition

Condition

Healthy adults

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To validate anti-allergic effects of daily ingestion of Lactococcus lactis subsp. cremoris YRC3780 for 12 weeks.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Total nasal symptom score, total ocular symptom score
(Measurement time: Before starting the ingestion of test meals. 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 weeks after the ingestion of test meals. And 1 and 2 weeks after the end of ingestion of test meals.)

Key secondary outcomes

Symptom score (sneezing, runny nose, stuffy nose, itchy eyes, watery eyes, throat symptoms and inconvenience for daily life), total symptom score, medication score, symptom-medication score (SMS), nasal SMS, ocular SMS, total IgE, white birch pollen-specific IgE, Th1/Th2 cytokine (IFN-gamma, IL-10), TARC, eosinophil count and WBC differential count


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

No need to know


Intervention

No. of arms

4

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Ingestion of capsules containing high-dose Lactococcus lactis subsp. cremoris YRC3780 daily for 12 weeks.

Interventions/Control_2

Ingestion of capsules containing middle-dose Lactococcus lactis subsp. cremoris YRC3780 daily for 12 weeks.

Interventions/Control_3

Ingestion of capsules containing low- dose Lactococcus lactis subsp. cremoris YRC3780 daily for 12 weeks.

Interventions/Control_4

Ingestion of placebo capsules daily for 12 weeks.

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

1. Subjects suffering from nasal or ocular discomfort caused by white birch pollen.
2. Subjects who were positive for skin prick test to white birch pollen.
3. Subjects who agree to participate in this study with a written informed consent.

Key exclusion criteria

1. Subjects who have a past history of serious allergic reactions (anaphylaxis, etc.).
2. Subjects with acute rhinitis, sinusitis, nasal polyps, hypertrophic rhinitis and/or severely deviated nasal septum, etc.
3. Subjects with bronchial asthma.
4. Subject who are under immunotherapy such as specific desensitization therapy.
5. Subjects with serious cerebrovascular, cardiac, hepatic, renal, gastrointestinal diseases, disorder of endocrine and metabolism or affected with infectious diseases which are required to report to the authorities.
6. Subjects who have a major surgical history related to digestive system such as gastrectomy, gastrorrhaphy, enterectomy, etc.
7. Subjects with abnormal blood pressure or hematological data.
8. Subjects with serious anemia.
9. Pre- or post-menopausal women with complaints of obvious physical changes.
10. Subjects with a history of allergy to medicine and/or food (especially milk and corn).
11. Subjects who regularly take drugs which may affect evaluation of the current study (antihistamines, anti-allergic drugs, steroids, vasoconstrictors, anti-inflammatory drugs, anti-rheumatic drugs, antibiotics, immunosuppressive drugs and/or lactobacillus preparation, etc.).
12. Heavy smokers, alcohol addicts or subjects with irregular lifestyle.
13. Subjects who donated either 400ml whole blood within 12 weeks or 200ml whole blood within 4 weeks or blood components within 2 weeks prior to the current study.
14. Pregnant or lactating women or women expect to be pregnant during the study.
15. Subjects who participate in other clinical trials within the last one month prior to this study.
16. Any other medical reasons judged by the principal investigator.

Target sample size

96


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Prof. Jun NISHIHIRA, M.D., Ph.D.

Organization

Hokkaido Information University

Division name

Department of Medical Management and Informatics

Zip code


Address

59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan

TEL

011-385-4411

Email

nishihira@do-johodai.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Dir. Prof. Jun NISHIHIRA, M.D., Ph.D.

Organization

Hokkaido Information University

Division name

Health Information Science Center

Zip code


Address

59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan

TEL

011-385-4430

Homepage URL


Email

nishihira@do-johodai.ac.jp


Sponsor or person

Institute

Hokkaido Information University

Institute

Department

Personal name



Funding Source

Organization

Yotsuba Milk Products Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan


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

北海道情報大学　保健センター（北海道）


Other administrative information

Date of disclosure of the study information

2016 Year 02 Month 26 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

2016 Year 01 Month 29 Day

Date of IRB


Anticipated trial start date

2016 Year 02 Month 26 Day

Last follow-up date

2016 Year 07 Month 05 Day

Date of closure to data entry

2016 Year 07 Month 26 Day

Date trial data considered complete

2016 Year 08 Month 02 Day

Date analysis concluded

2016 Year 12 Month 31 Day


Other

Other related information



Management information

Registered date

2016 Year 02 Month 26 Day

Last modified on

2017 Year 06 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024463