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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000024464
Receipt No. R000028155
Scientific Title Confirmation trial for the ameliorating effects of lactobacillus acidophilus strain L-92 on borderline symptoms of perennial allergic rhinitis
Date of disclosure of the study information 2016/10/19
Last modified on 2017/02/21

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Basic information
Public title Confirmation trial for the ameliorating effects of lactobacillus acidophilus strain L-92 on borderline symptoms of perennial allergic rhinitis
Acronym Confirmation trial for the ameliorating effects of lactobacillus acidophilus strain L-92 on borderline symptoms of perennial allergic rhinitis
Scientific Title Confirmation trial for the ameliorating effects of lactobacillus acidophilus strain L-92 on borderline symptoms of perennial allergic rhinitis
Scientific Title:Acronym Confirmation trial for the ameliorating effects of lactobacillus acidophilus strain L-92 on borderline symptoms of perennial allergic rhinitis
Region
Japan

Condition
Condition Healthy Adult
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the ameliorating effects of lactobacillus acidophilus strain L-92 on borderline symptoms of perennial allergic rhinitis
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Amelioration in subjective symptoms of perennial allergic rhinitis after 4 or 8 weeks intervention
Key secondary outcomes After 4 or 8 weeks intervention, local findings, antigen-specific IgE(house dust, Dermatophagoides pteronyssinus, Dermatophagoides farinae, night fly, animal epithelial, total IgE), questionnaires on subjective symptoms, medical interview(including findings), body weight, body height, BMI, blood pressure, pulse rate, Blood tests(leukocyte count, erythrocyte count, hemoglobin, hematocrit, platelet count, MCV, MCH, MCHC, leukocyte picture, total protein, albumin, AST(GOT), ALT(GPT), LD(LDH), total bilirubin, ALP, g-GT(g-GTP), CK(CPK), urea nitrogen(UN), uric acid level, creatinine, Na, Cl, K, Ca, total cholesterol, LDL-cholesterol, HDL-cholesterol, TG(neutral fat), fasting blood sugar, HbA1c, insulin, urinary test(protein, sugar, occult blood reaction, urobilinogen, pH, specific gravity)

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 NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Daily intakes of tablets including Lactobacillus acidophilus strain L-92 for 8 weeks
Interventions/Control_2 Daily intakes of tablets not including Lactobacillus acidophilus strain L-92 for 8 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

Not applicable
Gender Male and Female
Key inclusion criteria 1.Healthy adult who have a discomfort in eyes and noses by house dust in daily life.
2.Suffering from borderline symptoms of perennial allergic rhinitis.
3.Getting a positive for specific IgE against house dust in the screening test.
4.Not interpreted positive by the principal investigator as a result of specific IgE against seasonal antigens in the screening test.
5.Suffering from borderline symptoms of perennial allergic rhinitis interpreted by the principal investigator from weekly symptoms before screening test.
6.Giving priority to those who have edema in the mucous of inferior nasal concha.
7.Being informed fully about the purpose and the contents of the clinical trial and having the ability to consent. Those who hope spontaneously with understanding of the trial and consent to take part in the trial in writing.
Key exclusion criteria 1.Suffering from a disease requiring treatment urgently, and having a chronic disease except for perennial allergic rhinitis.
2.Suffering from acute rhinitis, paranasal sinusitis, nasal polyp, hypertrophic rhinitis, deflected septum.
3.Being associated with bronchial asthma.
4.Suffering from serious disease of liver, kidney, heart, respiratory apparatus, internal secretion, or metabolism.
5.Practicing specific hyposensitization therapy.
6.Using oral medicines or nose drops such as antihistamine or anti-allergic agent, and using other medicines.
7.Daily intakes of preparations or supplements including lactic acid bacteria.
8.Daily intakes of yogurt or foods which have the effect of anti-allergy such as Tencha(sweet tea).
9.Suspected to be allergic to ingredients of the test material.
10.Being pregnant, likely to be pregnant, or breast-feeding.
11.Participants in other clinical tests like having foods or using medicines. Participants in other clinical tests like putting on cosmetics or medical application.
12.Participants or likely to be participants in other clinical tests within a month before getting consent.
13.Being interpreted unsuitable for a subject by the principal investigator.
Target sample size 160

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tsugutami Onodera
Organization Sapporo Yurinokai Hospital
Division name Director
Zip code
Address 11-186 Yurigahara, Kita-ku, Sapporo, Hokkaido
TEL 011-771-1501
Email takahashi@yurinokaihp.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshika Komori
Organization KSO Corporation
Division name Sales department
Zip code
Address 1-9-7 Shibaura, Minato-ku, Tokyo
TEL 03-3452-7733
Homepage URL
Email yoshi@kso.co.jp

Sponsor
Institute Sapporo Yurinokai Hospital
Institute
Department

Funding Source
Organization Asahi Group Holdings, 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
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

Other administrative information
Date of disclosure of the study information
2016 Year 10 Month 19 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 Preinitiation
Date of protocol fixation
2016 Year 08 Month 29 Day
Date of IRB
Anticipated trial start date
2016 Year 10 Month 19 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 10 Month 18 Day
Last modified on
2017 Year 02 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028155

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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