Probiotics and Allergic Diseases (probiotics)

GenMont Biotech

Status: Completed

Conditions: Atopic Dermatitis; Asthma

Treatments: Biological: LP GMNL-133 +LF GM-090 capsule; Biological: Placebo; Biological: LP GMNL-133 capsule; Biological: LF GM-090 capsule

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01635738

TH-IRB-10-14

Details and patient eligibility

About

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.

Full 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.

Enrollment: 240 patients

Sex: All

Ages: 1 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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240 participants in 4 patient groups, including a placebo group

LP GMNL-133 group

Experimental group

Description:

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

Treatment:

Biological: LP GMNL-133 capsule

LF GM-090 group

Experimental group

Description:

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

Treatment:

Biological: LF GM-090 capsule

LP GMNL-133+LF GM-090 group

Experimental group

Description:

One capsule with 2x10\^9 (cfu) LP GMNL-133+ 2x10\^9 (cfu)LF GM-090, once daily, PO

Treatment:

Biological: LP GMNL-133 +LF GM-090 capsule

Placebo

Placebo Comparator group

Treatment:

Biological: Placebo