Taipei Hospital, Department of Health, Taiwan, R.O.C.
New Taipei City, 24213, Taiwan
NCT Number: NCT01635738
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.
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Notify Me1 year–18 year
All sexes
Interventional
Not applicable
New Taipei City, 24213, Taiwan
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
One capsule with 2x10^9 (cfu) LP GMNL-133, once daily, PO
Arm: LF GM-090 group One capsule with 2x10^9 (cfu) LF GM-090, once daily, PO
One capsule with 4x10^9 (cfu) LP GMNL-133 +LF GM-090, once daily, PO
Placebo
Time frame: 2 years
Primary Endpoints:
SCORAD score, Children's Dermatology Life Quality Index (CDLQI), and Dermatitis Family Impact Questionnaire
Primary Endpoints:
GINA guideline asthma severity ( step up or step down) ACT, PAQLQ, PACQLQ, PASS Questionnaire
Primary Endpoints:
ARIA allergic rhinitis severity PRQLQ, NTSS Questionnaire
Time frame: 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.
GenMont Biotech Incorporation
Industry
Acronym: probiotics
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