UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Confirmation trial for the ameliorating effects of lactobacillus acidophilus strain L-92 on borderline symptoms of perennial allergic rhinitis
Title of the study (Brief title)	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	Tsugutami Onodera
Organization	Sapporo Yurinokai Hospital
Division name	Director
Address	11-186 Yurigahara, Kita-ku, Sapporo, Hokkaido
TEL	011-771-1501
Email	takahashi@yurinokaihp.or.jp

Public contact
Name of contact person	Yoshika Komori
Organization	KSO Corporation
Division name	Sales department
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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 08 Month 29 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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