NCT01635738

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 4, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 10, 2012

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

September 2, 2015

Status Verified

August 1, 2015

Enrollment Period

2.5 years

First QC Date

July 4, 2012

Last Update Submit

August 31, 2015

Conditions

Atopic DermatitisAsthma

Keywords

ProbioticsLactobacillus paracasei GMNL-133Lactobacillus fermentum GM-090Atopic dermatitisAsthmaLactobacillus paracaseiLactobacillus fermentumefficacy and safety

Outcome Measures

Primary Outcomes (1)

  • The Effects of probiotics in improving life quality and symptomatic severity

    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

    2 years

Secondary Outcomes (1)

  • The Effects of probiotics on biomakers and other symptom relief

    2 years

Study Arms (4)

LP GMNL-133 group

EXPERIMENTAL

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

Biological: LP GMNL-133 capsule

LF GM-090 group

EXPERIMENTAL

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

Biological: LF GM-090 capsule

LP GMNL-133+LF GM-090 group

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR
Biological: Placebo

Interventions

LP GMNL-133 capsuleBIOLOGICAL

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

LP GMNL-133 group
LF GM-090 capsuleBIOLOGICAL

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

LF GM-090 group
LP GMNL-133 +LF GM-090 capsuleBIOLOGICAL

One capsule with 4x10\^9 (cfu) LP GMNL-133 +LF GM-090, once daily, PO

LP GMNL-133+LF GM-090 group
PlaceboBIOLOGICAL

Placebo

Placebo

Eligibility Criteria

Age1 Year - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

New Taipei City, 24213, Taiwan

Location

Related Publications (6)

  • 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.

    PMID: 20204477RESULT

  • 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.

    PMID: 20003066RESULT

  • 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.

    PMID: 18800885RESULT

  • 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.

    PMID: 16101937RESULT

  • 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.

    PMID: 15059192RESULT

  • 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.

    PMID: 25600169DERIVED

MeSH Terms

Conditions

Dermatitis, AtopicAsthma

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System DiseasesBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory Hypersensitivity

Study Officials

  • I-Jen Wang, Doctor

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

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 4, 2012

First Posted

July 10, 2012

Study Start

December 1, 2011

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

September 2, 2015

Record last verified: 2015-08

Locations

TW(1)