Probiotics and Allergic Diseases

Asthma Clinical Trial

— probiotics  

Official title:

Probiotics and Allergic Diseases

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01635738
• Other study ID #: TH-IRB-10-14
• Status: Completed
• Phase: N/A
• First received: July 4, 2012
• Last updated: August 31, 2015
• Start date: December 2011
• Est. completion date: June 2014

Study information

• Verified date: August 2015
• Source: GenMont Biotech Incorporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 18 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Asthma
• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Biological:
• LP GMNL-133 capsule
One capsule with 2x10^9 (cfu) LP GMNL-133, once daily, PO
• LF GM-090 capsule
Arm: LF GM-090 group One capsule with 2x10^9 (cfu) LF GM-090, once daily, PO
• LP GMNL-133 +LF GM-090 capsule
One capsule with 4x10^9 (cfu) LP GMNL-133 +LF GM-090, once daily, PO
• Placebo
Placebo

Locations

Country	Name	City	State
Taiwan	Taipei Hospital, Department of Health, Taiwan, R.O.C.	New Taipei City

Sponsors (2)

Lead Sponsor	Collaborator
GenMont Biotech Incorporation	National Science Council, Taiwan

Country where clinical trial is conducted

Taiwan, 

References & Publications (5)

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 M — View 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. — View 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. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	2 years	No
Secondary	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.	2 years	Yes