Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Probiotics and Allergic Diseases (probiotics)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01635738
Recruitment Status : Completed
First Posted : July 10, 2012
Last Update Posted : September 2, 2015
Sponsor:
Collaborator:
National Science Council, Taiwan
Information provided by (Responsible Party):
GenMont Biotech Incorporation

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Asthma Biological: LP GMNL-133 capsule Biological: LF GM-090 capsule Biological: LP GMNL-133 +LF GM-090 capsule Biological: Placebo Not Applicable

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.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Probiotics and Allergic Diseases
Study Start Date : December 2011
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma Eczema

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. The Effects of probiotics in improving life quality and symptomatic severity [ Time Frame: 2 years ]

    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 :
  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.



Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01635738


Locations
Layout table for location information
Taiwan
Taipei Hospital, Department of Health, Taiwan, R.O.C.
New Taipei City, Taiwan, 24213
Sponsors and Collaborators
GenMont Biotech Incorporation
National Science Council, Taiwan
Investigators
Layout table for investigator information
Study Chair: I-Jen Wang, Doctor Taipei Hospital, Department of Health, Taiwan, R.O.C.
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: GenMont Biotech Incorporation
ClinicalTrials.gov Identifier: NCT01635738    
Other Study ID Numbers: TH-IRB-10-14
First Posted: July 10, 2012    Key Record Dates
Last Update Posted: September 2, 2015
Last Verified: August 2015
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:
Layout table for MeSH terms
Dermatitis, Atopic
Dermatitis
Eczema
Hypersensitivity, Immediate
Hypersensitivity
 Immune System Diseases
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous