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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036317
Receipt No. R000041189
Scientific Title Effect of plant-derived lactic acid bacterium-fermented fruit juice powder on perennial allergy status
Date of disclosure of the study information 2019/03/28
Last modified on 2019/10/04

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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 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 Open public recruiting
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 02 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 03 Month 27 Day
Last modified on
2019 Year 10 Month 04 Day


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

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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