Probiotics and Allergic Diseases

Study Overview
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Brief Summary
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Many studies had demonstrated that probiotics could be applied in the prevention and adjuvant treatment for allergic diseases. In this study, we investigate the effects of Lactobacillus paracasei GMNL-133(LP), Lactobacillus fermentum GM-090 (LF), and Lactobacillus paracasei GMNL-133(LP) with Lactobacillus fermentum GM-090 (LF) combination products used for adjuvant treatment of atopic dermatitis and asthma.

Detailed Description
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The main purpose: To investigate if Lactobacillus paracasei GMNL-133(LP), Lactobacillus fermentum GM-090(LF), Lactobacillus paracasei GMNL-133 (LP) with Lactobacillus fermentum GM-090 (LF) combination products could be used for the adjuvant treatment of atopic dermatitis and asthma. The Secondary Objective: To investigate whether probiotics consumption improve the quality of life and allergic symptoms to different people with Lactobacillus paracasei GMNL-133 (LP), Lactobacillus fermentum GM-090 (LF) and Lactobacillus paracasei GMNL-133(LP) and Lactobacillus fermentum GM-090 (LF) combination products.

Official Title
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Probiotics and Allergic Diseases

Conditions
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Atopic Dermatitis, Asthma

Intervention / Treatment
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* Biological: LP GMNL-133 capsule
* Biological: LF GM-090 capsule
* Biological: LP GMNL-133 +LF GM-090 capsule
* Biological: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 1 year old and 18 years old, AD cases fulfill the diagnostic criteria by Hannifin and Rajka. Atopy as shown by at least one positive skin test (weal size ≧ 3mm) or one positive MAST (RAST) (IgE ≧ 0.7 kU/L) test to any common food or environmental allergens. Exclusion Criteria: Systematic corticosteroid, immunosuppressive therapy, or antimycotics treatment during the 4 weeks, antihistamines, and singulair during the 7 days before enrollment Probiotic preparations used within 2 weeks before entering the study Use of antibiotics now or other oral medications that will interfere the results If they had immune deficiency disease or other major medical problems If they had participated in another clinical study during the past month. Subjects are undergoing desensitization therapy within 3 months prior to the screening period. Subjects have participated investigational drug trial within 4 weeks before entering this study. Subjects are pregnant, lactating or planning to become pregnant. Subjects with any other serious diseases considered by the investigator that could interfere with the performance of SCORAD score result. Subjects who is lack of physical integrity of gastrointestinal tract, or malabsorption syndrome, or inability to take oral medication.

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LP GMNL-133 group<br>Arm: LP GMNL-133 group One capsule with 2x10^9 (cfu) LP GMNL-133, once daily, PO | Biological: LP GMNL-133 capsule<br>* One capsule with 2x10^9 (cfu) LP GMNL-133, once daily, PO<br>|
| Experimental: LF GM-090 group<br>Arm: LF GM-090 group One capsule with 2x10^9 (cfu) LF GM-090, once daily, PO | Biological: LF GM-090 capsule<br>* Arm: LF GM-090 group One capsule with 2x10^9 (cfu) LF GM-090, once daily, PO<br>|
| Experimental: LP GMNL-133+LF GM-090 group<br>One capsule with 2x10^9 (cfu) LP GMNL-133+ 2x10^9 (cfu)LF GM-090, once daily, PO | Biological: LP GMNL-133 +LF GM-090 capsule<br>* One capsule with 4x10^9 (cfu) LP GMNL-133 +LF GM-090, once daily, PO<br>|
| Placebo Comparator: Placebo<br> | Biological: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Effects of probiotics in improving life quality and symptomatic severity | Atopic dermatitis Primary Endpoints: SCORAD score, Children's Dermatology Life Quality Index (CDLQI), and Dermatitis Family Impact Questionnaire Asthma Primary Endpoints: GINA guideline asthma severity ( step up or step down) ACT, PAQLQ, PACQLQ, PASS Questionnaire Allergic Rhinitis Primary Endpoints: ARIA allergic rhinitis severity PRQLQ, NTSS Questionnaire | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Effects of probiotics on biomakers and other symptom relief | Atopic dermatitis: Decrease topical steroid and oral antihistamine use, changes of skin prick test severity, effect persistency after discontinuing Lactobacillus paracasei GMNL-133, Lactobacillus fermentum GM-090 or the composition of Lactobacillus paracasei GMNL-133 and Lactobacillus fermentum GM-090 intake, changes of cytokine and IgE, urine EPX, 8-ohdg biomarkers. Comparison of Probiotic group (LP, LF and LP+LF) and placebo group Asthma: Peak flow lung function, the changes of skin prick test severity, effect persistency after discontinuing probiotics, ISAAC questionnaire, use of rescue medication, unscheduled visit to emergency unit, changes of cytokine and IgE, urine EPX, 8-ohdg biomarkers Comparison of Probiotic group (LP, LF and LP+LF) and placebo group Allergic Rhinitis : Changes of skin prick test severity, effect persistency after discontinuing probiotics, ISAAC questionnaire, use of rescue medication, changes of cytokine and IgE, urine EPX, 8-ohdg biomarkers. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Probiotics, Lactobacillus paracasei GMNL-133, Lactobacillus fermentum GM-090, Atopic dermatitis, Asthma, Lactobacillus paracasei, Lactobacillus fermentum, efficacy and safety