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| Name | Class |
|---|---|
| Methodex | INDUSTRY |
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To assess the efficacy and safety of the use of probiotics as food supplements in reducing the SCORAD index in children with atopic skin compared with placebo. This is a randomized, placebo-controlled, double-blind clinical trial with 2 parallel groups, which will include 32 patients who attend some of the research centers. Patients will be randomized into one of the 2 study groups (allocation ratio 1: 1): Experimental group (Lactobacillus rhamnosus LRa05) and placebo group (placebo). The reduction of the SCORAD index, the number of sprouts in 12 weeks, the days of use of topical corticosteroids and one valuations of the skin condition (hydration).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo group | Placebo Comparator | 2.0 g maltodextrin /sachetï¼› Take one sachet a day before meals. Dilute in waterï¼› Store in a cool, dry place without sun exposure. |
|
| Probiotic group | Active Comparator | (2B CFU/sachet) Lactobacillus rhamnosus LRa05 and maltodextrin Take one sachet a day before meals. Dilute in waterï¼› Store in a cool, dry place without sun exposure. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| probiotic LRa05 | Dietary Supplement | treatment about 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| the outbreaks of atopic skin | use the SCORAD index to measure the outbreaks of atopic skin | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CAP Alhambra of Hospitalet de Llobregat | Barcelona | Spain | ||||
| CAP La Mina Carrer Mar Sant Adrià de Besos |
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| ID | Term |
|---|---|
| D004485 | Eczema |
| ID | Term |
|---|---|
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
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| Barcelona |
| Spain |