Probiotics and Allergic Diseases

Not Applicable

Completed

• Conditions: Asthma; Atopic Dermatitis
• Interventions: Biological: LF GM-090 capsule; Biological: Placebo; Biological: LP GMNL-133 capsule; Biological: LP GMNL-133 +LF GM-090 capsule

• Registration Number: NCT01635738
• Lead Sponsor: GenMont Biotech Incorporation

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.

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2012-07-04
• Study First Submitted QC: 2012-07-09
• Study First Posted: 2012-07-10
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-31
• Last Update Posted: 2015-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LF GM-090 group	LF GM-090 capsule	Arm: LF GM-090 group One capsule with 2x10\^9 (cfu) LF GM-090, once daily, PO
Placebo	Placebo	-
LP GMNL-133 group	LP GMNL-133 capsule	Arm: LP GMNL-133 group One capsule with 2x10\^9 (cfu) LP GMNL-133, once daily, PO
LP GMNL-133+LF GM-090 group	LP GMNL-133 +LF GM-090 capsule	One capsule with 2x10\^9 (cfu) LP GMNL-133+ 2x10\^9 (cfu)LF GM-090, once daily, PO

Primary Outcome Measures

Name	Time	Method
The Effects of probiotics in improving life quality and symptomatic severity	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

Name	Time	Method
The Effects of probiotics on biomakers and other symptom relief	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.

Trial Locations

Locations (1)

Taipei Hospital, Department of Health, Taiwan, R.O.C.; 🇨🇳 New Taipei City, Taiwan