Probiotics and Allergic Diseases (probiotics)

August 31, 2015 updated by: GenMont Biotech Incorporation
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

240

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • New Taipei City, Taiwan, 24213
        • Taipei Hospital, Department of Health, Taiwan, R.O.C.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 months to 16 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Biological: Placebo
Placebo
Experimental: LP GMNL-133 group
Arm: LP GMNL-133 group One capsule with 2x10^9 (cfu) LP GMNL-133, once daily, PO
Biological: LP GMNL-133 capsule
One capsule with 2x10^9 (cfu) LP GMNL-133, once daily, PO
Experimental: LF GM-090 group
Arm: LF GM-090 group One capsule with 2x10^9 (cfu) LF GM-090, once daily, PO
Biological: LF GM-090 capsule
Arm: LF GM-090 group One capsule with 2x10^9 (cfu) LF GM-090, once daily, PO
Experimental: LP GMNL-133+LF GM-090 group
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
One capsule with 4x10^9 (cfu) LP GMNL-133 +LF GM-090, once daily, PO

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Effects of probiotics on biomakers and other symptom relief
Time Frame: 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.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GenMont Biotech Incorporation

Collaborators

National Science Council, Taiwan

Investigators

  • Study Chair: I-Jen Wang, Doctor, Taipei Hospital, Department of Health, Taiwan, R.O.C.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

July 4, 2012

First Submitted That Met QC Criteria

July 9, 2012

First Posted (Estimate)

July 10, 2012

Study Record Updates

Last Update Posted (Estimate)

September 2, 2015

Last Update Submitted That Met QC Criteria

August 31, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TH-IRB-10-14

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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