Probiotics and Allergic Diseases (probiotics)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by GenMont Biotech Incorporation
Sponsor:
Collaborator:
National Science Council, Taiwan
Information provided by (Responsible Party):
GenMont Biotech Incorporation
ClinicalTrials.gov Identifier:
NCT01635738
First received: July 4, 2012
Last updated: December 9, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention
Atopic Dermatitis
Asthma
Biological: LP GMNL-133 capsule
Biological: LF GM-090 capsule
Biological: LP GMNL-133 +LF GM-090 capsule
Biological: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Probiotics and Allergic Diseases

Resource links provided by NLM:


Further study details as provided by GenMont Biotech Incorporation:

Primary Outcome Measures:
  • The Effects of probiotics in improving life quality and symptomatic severity [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • The Effects of probiotics on biomakers and other symptom relief [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

    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.



Estimated Enrollment: 360
Study Start Date: December 2011
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
One capsule with 2x10^9 (cfu) LP GMNL-133, once daily, PO
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
Arm: LF GM-090 group One capsule with 2x10^9 (cfu) LF GM-090, once daily, PO
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
One capsule with 4x10^9 (cfu) LP GMNL-133 +LF GM-090, once daily, PO
Placebo Comparator: Placebo Biological: Placebo
Placebo

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

Ages Eligible for Study:   1 Year to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01635738

Contacts
Contact: I-Jen Wang, Doctor 886-2-2765566 ext 2532 r92846001@ntu.edu.tw
Contact: Zeing Liao, Master 886-6-5052151 ext 325 zeing@genmont.com.tw

Locations
Taiwan
Taipei Hospital, Department of Health, Taiwan, R.O.C. Recruiting
New Taipei City, Taiwan, 24213
Contact: I-Jen Wang, doctor    886-2-2765566 ext 2532    r92846001@ntu.edu.tw   
Contact: Zeing Liao, Master    886-6-5052151 ext 325    zeing@genmont.com.tw   
Sub-Investigator: Zeing Liao, Master         
Sponsors and Collaborators
GenMont Biotech Incorporation
National Science Council, Taiwan
Investigators
Study Chair: I-Jen Wang, Doctor Taipei Hospital, Department of Health, Taiwan, R.O.C.
  More Information

Publications:
Responsible Party: GenMont Biotech Incorporation
ClinicalTrials.gov Identifier: NCT01635738     History of Changes
Other Study ID Numbers: TH-IRB-10-14
Study First Received: July 4, 2012
Last Updated: December 9, 2012
Health Authority: Taiwan: Institutional Review Board

Keywords provided by GenMont Biotech Incorporation:
Probiotics
Lactobacillus paracasei GMNL-133
Lactobacillus fermentum GM-090
Atopic dermatitis
Asthma
Lactobacillus paracasei
Lactobacillus fermentum
efficacy and safety

Additional relevant MeSH terms:
Asthma
Dermatitis
Dermatitis, Atopic
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous

ClinicalTrials.gov processed this record on August 20, 2014