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The primary objective of this trial is to assess the efficacy of the consumption of heat-treated Lactobacillus paracasei (GM080) on atopic dermatitis as compared to a placebo treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Maltodextrin | Placebo Comparator | Maltodextrin |
|
| GM080 | Active Comparator | GM080 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GM080 | Dietary Supplement |
| ||
| Maltodextrin |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline SCORAD Score at 16 weeks of treatment | SCORAD documented during the longitudinal observational period of 16 weeks after the subject has enrolled | between 0 and 16 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Score A, B and C of the SCORAD | Score A, B and C of the SCORAD The scores A, B and C of the SCORAD as well as the subcategories of the scores B and C will be analyzed separately (measured at V0c, V1, V2 and V3) | 0, 4, 10 and 16 weeks of treatment |
| Number and duration of atopic dermatitis episodes |
| Measure | Description | Time Frame |
|---|---|---|
| Diaper rash episodes and duration will be recorded by the parents/caregivers | Diaper rash episodes and duration will be recorded by the parents/caregivers | duting the 16 weeks of treatment |
| Perception/impression of the ingredient by the caregiver |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaohsiung Municipal TA-TUNG Hospital | Kaohsiung City | Qianjin District | 801 | Taiwan | ||
| Kaohsiung Municipal Hsiao-Kang Hospital |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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| ID | Term |
|---|---|
| C008315 | maltodextrin |
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|
Number and duration of atopic dermatitis episodes The number of episodes of atopic dermatitis and the total number of days with symptoms during the 16 weeks intervention period |
| during the 16 weeks intervention period |
| Transepidermal water loss | TEWL will be measured at V0, V1, V2 and V3 on 4 sites of both non-lesional and lesional appearing skin parts | 0, 4, 10 and 16 weeks |
| Topical treatment used | Topical treatment used (sparing effect) The corticoid sparing effect of the ingredient will be assessed in the placebo and the ingredient group. | during the 16 weeks of treatment |
| total and specific IgE | total and specific IgE | 0 and 16 weeks |
| Quality of Life | The infants' dermatitis quality of life index (IDQOL) will be collected | 0, 4, 10, 16 weeks and 1 and 4 years later |
| assess the effect of the product on the safety parameters | Biochemistry and Hematology parameters | 0 and 16 weeks |
| "Objective" SCORAD, which is composed of part A and B of the SCORAD (measured at V0, V1, V2 and V3) | 0, 4, 10 and 16 weeks |
At the end of the 16 weeks intervention trial, the perception of the caregivers toward the ingredient they were randomized to, will be assessed
| at 16 weeks |
| Assessment of allergic history and skin disease | 1 and 4 years later |
| Cytokine quantification | Cytokine quantification (multiplex) will be assessed in plasma of the patients | 0 and 16 weeks of treatment |
| Genetic characterization of atopic dermatitis associated polymorphism | Five major mutations in the FLG gene, one polymorphism in SPINK5 and one insertion in KLK7 gene will be analyzed in blood DNA | 0 week |
| Kaohsiung City |
| Siaogang District |
| 812 |
| Taiwan |
| Taipei Chang Gung Memorial Hospital of the Chang-Gung Medical foundation | Taipei | Songshan District | 105 | Taiwan |
| Chung Shan Medical University Hospital | Taichung | South District | 402 | Taiwan |
| Linkou Chang Gung Memorial Hospital | Gueishan Township | Taoyuan County | 333 | Taiwan |
| Cardinal Tien Hospital | New Taipei City | Xindian District | 231 | Taiwan |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |