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Completed

NCT Number: NCT01635738

Probiotics and Allergic Diseases

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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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LP GMNL-133 capsule

Biological

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

LF GM-090 capsule

Biological

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

LP GMNL-133 +LF GM-090 capsule

Biological

One capsule with 4x10^9 (cfu) LP GMNL-133 +LF GM-090, once daily, PO

Placebo

Biological

Placebo

Primary outcomes

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

    Time frame: 2 years

    • 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

Secondary outcomes

  1. The Effects of probiotics on biomakers and other symptom relief

    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.

Sponsors and collaborators

Lead sponsor

GenMont Biotech Incorporation

Industry

Collaborators

  • National Science and Technology Council, Taiwan

Registry information

Acronym: probiotics

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Jul 10, 2012
Registry last updated
Sep 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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