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Probiotics and Allergic Diseases (probiotics)

Primary Purpose

Atopic Dermatitis, Asthma

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
LP GMNL-133 capsule
LF GM-090 capsule
LP GMNL-133 +LF GM-090 capsule
Placebo
Sponsored by
GenMont Biotech Incorporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Atopic Dermatitis focused on measuring Probiotics, Lactobacillus paracasei GMNL-133, Lactobacillus fermentum GM-090, Atopic dermatitis, Asthma, Lactobacillus paracasei, Lactobacillus fermentum, efficacy and safety

Eligibility Criteria

1 Year - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Taipei Hospital, Department of Health, Taiwan, R.O.C.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

LP GMNL-133 group

LF GM-090 group

LP GMNL-133+LF GM-090 group

Placebo

Arm Description

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

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

One capsule with 2x10^9 (cfu) LP GMNL-133+ 2x10^9 (cfu)LF GM-090, once daily, PO

Outcomes

Primary Outcome Measures

The Effects of probiotics in improving life quality and symptomatic severity
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 Outcome Measures

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.

Full Information

First Posted
July 4, 2012
Last Updated
August 31, 2015
Sponsor
GenMont Biotech Incorporation
Collaborators
National Science Council, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT01635738
Brief Title
Probiotics and Allergic Diseases
Acronym
probiotics
Official Title
Probiotics and Allergic Diseases
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GenMont Biotech Incorporation
Collaborators
National Science Council, Taiwan

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis, Asthma
Keywords
Probiotics, Lactobacillus paracasei GMNL-133, Lactobacillus fermentum GM-090, Atopic dermatitis, Asthma, Lactobacillus paracasei, Lactobacillus fermentum, efficacy and safety

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
240 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LP GMNL-133 group
Arm Type
Experimental
Arm Description
Arm: LP GMNL-133 group One capsule with 2x10^9 (cfu) LP GMNL-133, once daily, PO
Arm Title
LF GM-090 group
Arm Type
Experimental
Arm Description
Arm: LF GM-090 group One capsule with 2x10^9 (cfu) LF GM-090, once daily, PO
Arm Title
LP GMNL-133+LF GM-090 group
Arm Type
Experimental
Arm Description
One capsule with 2x10^9 (cfu) LP GMNL-133+ 2x10^9 (cfu)LF GM-090, once daily, PO
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Biological
Intervention Name(s)
LP GMNL-133 capsule
Intervention Description
One capsule with 2x10^9 (cfu) LP GMNL-133, once daily, PO
Intervention Type
Biological
Intervention Name(s)
LF GM-090 capsule
Intervention Description
Arm: LF GM-090 group One capsule with 2x10^9 (cfu) LF GM-090, once daily, PO
Intervention Type
Biological
Intervention Name(s)
LP GMNL-133 +LF GM-090 capsule
Intervention Description
One capsule with 4x10^9 (cfu) LP GMNL-133 +LF GM-090, once daily, PO
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
The Effects of probiotics in improving life quality and symptomatic severity
Description
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
Time Frame
2 years
Secondary Outcome Measure Information:
Title
The Effects of probiotics on biomakers and other symptom relief
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
I-Jen Wang, Doctor
Organizational Affiliation
Taipei Hospital, Department of Health, Taiwan, R.O.C.
Official's Role
Study Chair
Facility Information:
Facility Name
Taipei Hospital, Department of Health, Taiwan, R.O.C.
City
New Taipei City
ZIP/Postal Code
24213
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
20204477
Citation
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.
Results Reference
result
PubMed Identifier
20003066
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.
Results Reference
result
PubMed Identifier
18800885
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.
Results Reference
result
PubMed Identifier
16101937
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.
Results Reference
result
PubMed Identifier
15059192
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.
Results Reference
result
PubMed Identifier
25600169
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.
Results Reference
derived

Learn more about this trial

Probiotics and Allergic Diseases

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