UMIN-CTR Clinical Trial
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|Unique ID issued by UMIN||UMIN000024464|
|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|
|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|
|Classification by specialty||
|Classification by malignancy||Others|
|Narrative objectives1||To investigate the ameliorating effects of lactobacillus acidophilus strain L-92 on borderline symptoms of perennial allergic rhinitis|
|Basic objectives -Others|
|Developmental phase||Not applicable|
|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)|
|Blinding||Double blind -all involved are blinded|
|Institution consideration||Institution is not considered as adjustment factor.|
|No. of arms||2|
|Purpose of intervention||Prevention|
|Type of intervention||
|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|
|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||
|Organization||Sapporo Yurinokai Hospital|
|Address||11-186 Yurigahara, Kita-ku, Sapporo, Hokkaido|
|Name of contact person||
|Division name||Sales department|
|Address||1-9-7 Shibaura, Minato-ku, Tokyo|
|Institute||Sapporo Yurinokai Hospital|
|Organization||Asahi Group Holdings, Ltd|
|Category of Funding Organization||Profit organization|
|Nationality of Funding Organization|
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|IRB Contact (For public release)|
|Org. issuing International ID_1|
|Org. issuing International ID_2|
|IND to MHLW|
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|Date of disclosure of the study information||
|URL releasing protocol|
|Publication of results||Unpublished|
|URL related to results and publications|
|Number of participants that the trial has enrolled|
|Results date posted|
|Results Delay Reason|
|Date of the first journal publication of results|
|Plan to share IPD|
|IPD sharing Plan description|
|Date of protocol fixation||
|Date of IRB|
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|Last follow-up date|
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|Date trial data considered complete|
|Date analysis concluded|
|Other related information|
|Last modified on||
|Link to view the page|
|Registered date||File name|
|Research case data specifications|
|Registered date||File name|
|Research case data|
|Registered date||File name|