Clinical trial NCT01635738: Probiotics and Allergic Diseases
Official title: Probiotics and Allergic Diseases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atopic Dermatitis
Asthma
Keywords: Probiotics
Lactobacillus paracasei GMNL-133
Lactobacillus fermentum GM-090
Atopic dermatitis
Asthma
Lactobacillus paracasei
Lactobacillus fermentum
efficacy and safety
Lead sponsor: GenMont Biotech Incorporation
Sponsor class: INDUSTRY
Collaborators: name: National Science and Technology Council, Taiwan
First posted: 2012-07-10
Enrollment: 240
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The Effects of probiotics in improving life quality and symptomatic severity
timeFrame: 2 years
Secondary outcomes:
measure: The Effects of probiotics on biomakers and other symptom relief
timeFrame: 2 years
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Taipei Hospital, Department of Health, Taiwan, R.O.C.
Study officials:
affiliation: Taipei Hospital, Department of Health, Taiwan, R.O.C.
name: I-Jen Wang, Doctor
role: STUDY_CHAIR
References:
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citation: Yao TC, Chang CJ, Hsu YH, Huang JL. Probiotics for allergic diseases: realities and myths. Pediatr Allergy Immunol. 2010 Sep;21(6):900-19. doi: 10.1111/j.1399-3038.2009.00955.x. Epub 2009 Dec 9.
citation: Park CW, Youn M, Jung YM, Kim H, Jeong Y, Lee HK, Kim HO, Lee I, Lee SW, Kang KH, Park YH. New functional probiotic Lactobacillus sakei probio 65 alleviates atopic symptoms in the mouse. J Med Food. 2008 Sep;11(3):405-12. doi: 10.1089/jmf.2007.0144.
citation: Peng GC, Hsu CH. The efficacy and safety of heat-killed Lactobacillus paracasei for treatment of perennial allergic rhinitis induced by house-dust mite. Pediatr Allergy Immunol. 2005 Aug;16(5):433-8. doi: 10.1111/j.1399-3038.2005.00284.x.
citation: Wang MF, Lin HC, Wang YY, Hsu CH. Treatment of perennial allergic rhinitis with lactic acid bacteria. Pediatr Allergy Immunol. 2004 Apr;15(2):152-8. doi: 10.1111/j.1399-3038.2004.00156.x.
citation: Wang IJ, Wang JY. Children with atopic dermatitis show clinical improvement after Lactobacillus exposure. Clin Exp Allergy. 2015 Apr;45(4):779-87. doi: 10.1111/cea.12489.