Probiotics and Allergic Diseases

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2014-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Probiotics and Health-related Quality of Life in Individuals With Seasonal Allergies

NCT02349711

Healthy

COMPLETED NA

Prevention Allergic Disease of Infant With Probiotics During Pregnancy and Neonatal Period

NCT00325273

Atopic Dermatitis Allergic Rhinitis Asthma

COMPLETED PHASE3

the Efficacy and Safety of Probiotics eN-Lac® Capsules of Children With Perennial Allergic Rhinitis

NCT01116778

Perennial Allergic Rhinitis Probiotics Lactobacillus Paracasei GMNL-32 (eN-Lac®)

COMPLETED PHASE3

Effect of a Probiotic on Grass Pollen Allergic Rhinitis Subjects

NCT01150253

Allergic Rhinitis

COMPLETED NA

Prevention of Asthma and Allergy by Probiotic Lactobacillus GG

NCT00490425

Allergic Asthma

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Atopic Dermatitis Asthma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

LP GMNL-133 group

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

Group Type EXPERIMENTAL

LP GMNL-133 capsule

Intervention Type BIOLOGICAL

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

LF GM-090 group

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

Group Type EXPERIMENTAL

LF GM-090 capsule

Intervention Type BIOLOGICAL

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

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

Group Type EXPERIMENTAL

LP GMNL-133 +LF GM-090 capsule

Intervention Type BIOLOGICAL

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

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

Placebo

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

LP GMNL-133 capsule

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

Intervention Type BIOLOGICAL

LF GM-090 capsule

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

Intervention Type BIOLOGICAL

LP GMNL-133 +LF GM-090 capsule

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

Intervention Type BIOLOGICAL

Placebo

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

1 Year

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No