UMIN-CTR Clinical Trial

Basic information
Public title	Effect of plant-derived lactic acid bacterium-fermented fruit juice powder on perennial allergy status
Acronym	Effect of plant-derived lactic acid bacterium-fermented fruit juice powder on perennial allergy status
Scientific Title	Effect of plant-derived lactic acid bacterium-fermented fruit juice powder on perennial allergy status
Scientific Title:Acronym	Effect of plant-derived lactic acid bacterium-fermented fruit juice powder on perennial allergy status
Region	Japan

Condition
Condition	Healthy volunteers
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effect of powdered plant-derived lactic acid bacterium (Lactobacillus paracasei IJH-SONE68)-fermented fruit juice on perennial allergy state in subjects with allergic conditions.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Changes from baseline of averaged self evaluation score about allergic conditions and VAS score in daily life difficulty. These are measured at every 4 weeks interval until week 12.
Key secondary outcomes	Changes from baseline of averaged total serum IgE and semi-quantitative specific IgE (for house dust 1, house dust 2, allergenic Poaceae, wild weeds, animal dandruff, and fungi). These are also measured at every 4 weeks interval until week 12.

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
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Subjects receive 4 capsules (1000 mg) / day containing IJH-SONE68-fermented pineapple juice powder (sterilized) for 12 weeks.
Interventions/Control_2	Subjects receive 4 placebo capsules (1000 mg) / day containing dextrin powder for 12 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	70 years-old >=
Gender	Male and Female
Key inclusion criteria	Subjects 1) who feel allergic conditions, such as sneeze, nasal mucus, stuffy nose, itchiness of eyes, teary eyes, and dull headache. 2) whose self evaluation score is greater than or equal to 8 and lesser than or equal to 20. 3) whose VAS score is greater than or equal to 40.
Key exclusion criteria	1) Allergy to pineapple 2) Taking drugs for chronic disease 3) In pregnancy or nursing a child 4) Taking functional food that may affect the allergic conditions 5) Participation in any clinical trial with in 90 days of the commencement of the trial
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Masafumi Middle name Last name Noda
Organization	Hiroshima University, Graduate School of Biomedical & Health Sciences
Division name	Probiotic Science for Preventive Medicine
Zip code	734-8553
Address	Kasumi 1-2-3, Minami-ku, Hiroshima 734-8553, Japan
TEL	082-257-5288
Email	bel@hiroshima-u.ac.jp

Public contact
Name of contact person	1st name Masafumi Middle name Last name Noda
Organization	Hiroshima University, Graduate School of Biomedical & Health Sciences
Division name	Probiotic Science for Preventive Medicine
Zip code	734-8553
Address	Kasumi 1-2-3, Minami-ku, Hiroshima 734-8553, Japan
TEL	082-257-5288
Homepage URL
Email	bel@hiroshima-u.ac.jp

Sponsor
Institute	Hiroshima University
Institute
Department

Funding Source
Organization	Asahi Kohsan Co., Ltd.
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	Ethics committee of Hiroshima University
Address	Kasumi 1-2-3, Minami-ku, Hiroshima 734-8553, Japan
Tel	082-257-5805
Email	kasumi-kenkyu@office.hiroshima-u.ac.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	広島大学病院 (広島県)

Other administrative information
Date of disclosure of the study information	2019 Year 03 Month 28 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	60
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 03 Month 06 Day
Date of IRB	2019 Year 03 Month 22 Day
Anticipated trial start date	2019 Year 05 Month 07 Day
Last follow-up date	2021 Year 08 Month 31 Day
Date of closure to data entry	2021 Year 09 Month 30 Day
Date trial data considered complete	2021 Year 09 Month 30 Day
Date analysis concluded	2021 Year 10 Month 31 Day

Other
Other related information	60 participants were already entered.

Management information
Registered date	2019 Year 03 Month 27 Day
Last modified on	2022 Year 03 Month 31 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041189