UMIN-CTR Clinical Trial

Basic information
Public title	Study of improvement of allergic nasal symptoms by Bifidobacteria
Acronym	Study of improvement of allergic symptoms by Bifidobacteria
Scientific Title	A study to investigate the effects of Bifidobacteria on allergic nasal symptoms: a randomized, double-blind, placebo-controlled, parallel-group comparative study
Scientific Title:Acronym	Effects of Bifidobacteria on allergic nasal symptoms
Region	Japan

Condition
Condition	None
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effect of intake of Bifidobacteria on allergic nasal symptoms.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Nasal symptom score (symptom score, medication score, symptom-medication score)
Key secondary outcomes	Japanese Rhino-conjunctivitis Quality of Life Questionnaire (Items related to the nose)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	NO
Dynamic allocation	NO
Institution consideration
Blocking
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Ingestion of food containing Bifidobacteria for 13 weeks
Interventions/Control_2	Ingestion of placebo for 13 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	65 years-old >
Gender	Male and Female
Key inclusion criteria	1) Healthy men and women aged more than 20 years, less than 65 years. 2) Subject with a history of allergic nasal symptoms in the past 2 years. 3) Subject who is positive for cedar pollinosis-specific IgE (class 2 or higher).
Key exclusion criteria	1) Subject who regularly take or took allergy medicine. 2) Subject with hepatic disease, renal dysfunction, cardiovascular disorder, gastrointestinal disorder, respiratory dysfunction, blood disease, autoimmune disease, endocrine disease, metabolic disease and these severe medical history (Excluding appendectomy). 3) Subject with serious allergy to specific medicine or food. 4) Subject who is pregnant or under lactation, or who is expected to be pregnant during the study. 5) Subject who takes part in other clinical study within the past month. 6) Subject who is ineligible due to physician's judgment.
Target sample size	140

Research contact person
Name of lead principal investigator	1st name Yoshitaka Middle name Last name Iwama
Organization	Nihonbashi Cardiology Clinic
Division name	Director
Zip code	103-0001
Address	Kyodo Bldg. #201, 13 - 4 Nihonbashikodenmacho, Chuo-ku, Tokyo
TEL	03-5641-4133
Email	yiwama@well-sleep.jp

Public contact
Name of contact person	1st name Eiji Middle name Last name Yoshikawa
Organization	KSO Corporation
Division name	President-director
Zip code	105-0023
Address	Shibaura Omodaka Bldg. 7F, 1-9-7 Shibaura, Minato-ku, Tokyo
TEL	03-3452-7733
Homepage URL
Email	yoshikawa@kso.co.jp

Sponsor
Institute	KSO Corporation
Institute
Department

Funding Source
Organization	Morinaga Milk Industry 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	Ethical Committee of Kobuna Orthopedics Clinic
Address	5-656-17 Joutou-machi, Maebashi-shi, Gunma, Japan
Tel	027-261-7600
Email	info@kobunaseikei.jp

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	2020 Year 01 Month 10 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	140
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	2019 Year 12 Month 17 Day
Date of IRB	2019 Year 12 Month 19 Day
Anticipated trial start date	2020 Year 01 Month 12 Day
Last follow-up date	2020 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 01 Month 06 Day
Last modified on	2021 Year 01 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000044544