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CompletedNCT01635738probioticsUpdated Sep 2, 2015

Probiotics and Allergic Diseases

An interventional study of LP GMNL-133 capsule and LF GM-090 capsule in Atopic Dermatitis and Asthma, sponsored by GenMont Biotech Incorporation. Completed at 1 site in Taiwan. Open to participants aged 1 Year to 18 Years. Per ClinicalTrials.gov, last updated 2015-09-02.

Sponsored by GenMont Biotech Incorporation · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
240
Allocation
Randomized
Ages
1 Year to 18 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Atopic Dermatitis
  • Asthma

Keywords

  • Probiotics
  • Lactobacillus paracasei GMNL-133
  • Lactobacillus fermentum GM-090
  • Atopic dermatitis
  • Asthma
  • Lactobacillus paracasei
  • Lactobacillus fermentum
  • efficacy and safety
03

In context

Dermatitis, Atopic

1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.

This study's enrollment of 240 is above the median of 83 across 1,125 interventional studies indexed under Dermatitis, Atopic.

Browse Dermatitis, Atopic studies →

Lead sponsor

GenMont Biotech Incorporation is the lead sponsor of 10 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year to 18 Years
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Care provider, Investigator, Outcomes assessor)
Enrollment
240 participants (actual)

Study arms

  • Experimental
    LP GMNL-133 group

    Arm: LP GMNL-133 group One capsule with 2x10\^9 (cfu) LP GMNL-133, once daily, PO

    Biological: LP GMNL-133 capsule

  • Experimental
    LF GM-090 group

    Arm: LF GM-090 group One capsule with 2x10\^9 (cfu) LF GM-090, once daily, PO

    Biological: LF GM-090 capsule

  • Experimental
    LP GMNL-133+LF GM-090 group

    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

  • Placebo comparator
    Placebo

    Biological: Placebo

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

06

What researchers measure

Primary outcomes

  1. The Effects of probiotics in improving life quality and symptomatic severity

    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

    Time frame: 2 years

Secondary outcomes

  1. 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.

    Time frame: 2 years

07

Study locations

1 site
  • Taipei Hospital, Department of Health, Taiwan, R.O.C.
    New Taipei City, 24213, Taiwan
08

References and documents

Publications

  • Hong HJ, Kim E, Cho D, Kim TS. Differential suppression of heat-killed lactobacilli isolated from kimchi, a Korean traditional food, on airway hyper-responsiveness in mice. J Clin Immunol. 2010 May;30(3):449-58. doi: 10.1007/s10875-010-9375-8. Epub 2010 Mar 5. PubMed 20204477 ↗
  • 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. PubMed 20003066 ↗
  • 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. PubMed 18800885 ↗
  • 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. PubMed 16101937 ↗
  • 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. PubMed 15059192 ↗
  • 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. PubMed 25600169 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 2, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01635738
Lead sponsor
GenMont Biotech Incorporation
Collaborators
National Science Council, Taiwan
Responsible party
Sponsor
First posted
Jul 10, 2012
Start date
Dec 2011
Primary completion
Jun 2014
Completion
Jun 2014
Last update
Sep 2, 2015

Study contacts

I-Jen Wang, Doctor
study chair · Taipei Hospital, Department of Health, Taiwan, R.O.C.

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.

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