Atopic DermatitisprobioticsNCT01635738
Probiotics and Allergic Diseases
A study testing LP GMNL-133 capsule, LF GM-090 capsule and LP GMNL-133 +LF GM-090 capsule in people with Atopic Dermatitis and Asthma, run by GenMont Biotech Incorporation at 1 site in Taiwan.
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… Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Atopic Dermatitis, Asthma
- What is being tested?
- LP GMNL-133 capsule, LF GM-090 capsule and LP GMNL-133 +LF GM-090 capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteTaiwan
- Study dates
- Dec 2011to Jun 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Taipei Hospital, Department of Health, Taiwan, R.O.C.
New Taipei City, 24213
About this study
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.
Read the 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.
- Conditions
- Atopic Dermatitis, Asthma
- Being tested
- LP GMNL-133 capsule, LF GM-090 capsule, LP GMNL-133 +LF GM-090 capsule, Placebo
- Keywords
- Probiotics, Lactobacillus paracasei GMNL-133, Lactobacillus fermentum GM-090, Atopic dermatitis, Asthma, Lactobacillus paracasei, Lactobacillus fermentum, efficacy and safety
- Medical subject headings
- Dermatitis, Atopic, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LP GMNL-133 capsuleBiological
One capsule with 2x10^9 (cfu) LP GMNL-133, once daily, PO
LF GM-090 capsuleBiological
Arm: LF GM-090 group One capsule with 2x10^9 (cfu) LF GM-090, once daily, PO
LP GMNL-133 +LF GM-090 capsuleBiological
One capsule with 4x10^9 (cfu) LP GMNL-133 +LF GM-090, once daily, PO
PlaceboBiological
Placebo
| Study group | Role | What they receive |
|---|---|---|
| LP GMNL-133 group | Experimental | Arm: LP GMNL-133 group One capsule with 2x10^9 (cfu) LP GMNL-133, once daily, PO Receives: 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 Receives: 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 Receives: Biological: LP GMNL-133 +LF GM-090 capsule |
| Placebo | Placebo comparator | Not described Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years
Secondary outcomes (1)
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2012 (estimated)
- Study startDec 2011
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- GenMont Biotech Incorporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Science and Technology Council, Taiwan
- Responsible party
- Sponsor
- Investigators
- I-Jen Wang, Doctor, Study chair, Taipei Hospital, Department of Health, Taiwan, R.O.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01635738
- Sponsor's protocol ID
- TH-IRB-10-14
- Acronym
- probiotics
- Status last verified
- Aug 2015
- First submitted
- 4 Jul 2012
- Last updated
- 2 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 20204477Yao 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.
PubMed 20003066Park 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.
PubMed 18800885Peng 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.
PubMed 16101937Wang 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.
PubMed 15059192Wang 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.
PubMed 25600169
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probiotics and Allergic Diseases
- ClinicalTrials.gov ID
- NCT01635738
- Acronym / sponsor ID
- probiotics / TH-IRB-10-14
- Conditions
- Atopic Dermatitis, Asthma
- Keywords
- Probiotics, Lactobacillus paracasei GMNL-133, Lactobacillus fermentum GM-090, Atopic dermatitis, Asthma, Lactobacillus paracasei, Lactobacillus fermentum, efficacy and safety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- GenMont Biotech IncorporationIndustry (pharma, biotech, devices)
- Collaborators
- National Science and Technology Council, Taiwan
- Study start
- Dec 2011
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 10 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| LP GMNL-133 group | Experimental | Biological: LP GMNL-133 capsuleArm: LP GMNL-133 group One capsule with 2x10^9 (cfu) LP GMNL-133, once daily, PO |
| LF GM-090 group | Experimental | Biological: LF GM-090 capsuleArm: LF GM-090 group One capsule with 2x10^9 (cfu) LF GM-090, once daily, PO |
| LP GMNL-133+LF GM-090 group | Experimental | Biological: LP GMNL-133 +LF GM-090 capsuleOne capsule with 2x10^9 (cfu) LP GMNL-133+ 2x10^9 (cfu)LF GM-090, once daily, PO |
| Placebo | Placebo comparator | Biological: Placebo |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LP GMNL-133 capsuleOne capsule with 2x10^9 (cfu) LP GMNL-133, once daily, PO | Biological | LP GMNL-133 group |
| LF GM-090 capsuleArm: LF GM-090 group One capsule with 2x10^9 (cfu) LF GM-090, once daily, PO | Biological | LF GM-090 group |
| LP GMNL-133 +LF GM-090 capsuleOne capsule with 4x10^9 (cfu) LP GMNL-133 +LF GM-090, once daily, PO | Biological | LP GMNL-133+LF GM-090 group |
| PlaceboPlacebo | Biological | Placebo |
Primary outcome
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
1 secondary outcome
The Effects of probiotics on biomakers and other symptom relief
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2015.
- Results publication: PubMed 20204477Hong 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 publication: PubMed 20003066Yao 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 publication: PubMed 18800885Park 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 publication: PubMed 16101937Peng 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 publication: PubMed 15059192Wang 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.
- Derived from this study: PubMed 25600169Wang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
I-Jen Wang, Doctor study chair
Taipei Hospital, Department of Health, Taiwan, R.O.C.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LP GMNL-133 capsule, LF GM-090 capsule and LP GMNL-133 +LF GM-090 capsule in people with Atopic Dermatitis and Asthma, run by GenMont Biotech Incorporation at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Effects of probiotics in improving life quality and symptomatic severity (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01635738, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2015.