Asthma, Atopic Dermatitis
Conditions
Keywords
Probiotics, Lactobacillus paracasei GMNL-133, Lactobacillus fermentum GM-090, Atopic dermatitis, Asthma, Lactobacillus paracasei, Lactobacillus fermentum, efficacy and safety
Brief summary
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
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.
Interventions
BIOLOGICALLP GMNL-133 capsule
One capsule with 2x10\^9 (cfu) LP GMNL-133, once daily, PO
BIOLOGICALLF GM-090 capsule
Arm: LF GM-090 group One capsule with 2x10\^9 (cfu) LF GM-090, once daily, PO
BIOLOGICALLP GMNL-133 +LF GM-090 capsule
One capsule with 4x10\^9 (cfu) LP GMNL-133 +LF GM-090, once daily, PO
BIOLOGICALPlacebo
Placebo
Sponsors
National Science and Technology Council, Taiwan
GenMont Biotech Incorporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
1. Age between 1 year old and 18 years old, 2. AD cases fulfill the diagnostic criteria by Hannifin and Rajka. 3. 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
1. Systematic corticosteroid, immunosuppressive therapy, or antimycotics treatment during the 4 weeks, antihistamines, and singulair during the 7 days before enrollment 2. Probiotic preparations used within 2 weeks before entering the study 3. Use of antibiotics now or other oral medications that will interfere the results 4. If they had immune deficiency disease or other major medical problems 5. If they had participated in another clinical study during the past month. 6. Subjects are undergoing desensitization therapy within 3 months prior to the screening period. 7. Subjects have participated investigational drug trial within 4 weeks before entering this study. 8. Subjects are pregnant, lactating or planning to become pregnant. 9. Subjects with any other serious diseases considered by the investigator that could interfere with the performance of SCORAD score result. 10. Subjects who is lack of physical integrity of gastrointestinal tract, or malabsorption syndrome, or inability to take oral medication.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Effects of probiotics in improving life quality and symptomatic severity | 2 years | 1. Atopic dermatitis Primary Endpoints: SCORAD score, Children's Dermatology Life Quality Index (CDLQI), and Dermatitis Family Impact Questionnaire 2. Asthma Primary Endpoints: GINA guideline asthma severity ( step up or step down) ACT, PAQLQ, PACQLQ, PASS Questionnaire 3. Allergic Rhinitis Primary Endpoints: ARIA allergic rhinitis severity PRQLQ, NTSS Questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Effects of probiotics on biomakers and other symptom relief | 2 years | 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. |
Countries
Taiwan
Outcome results
None listed