Atopic Dermatitis
Conditions
Keywords
All subjects of any ethnicity aged from 4 to 30 months with atopic dermatitis skin symptoms with a SCORAD equal or above 20
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTGM080
DIETARY_SUPPLEMENTMaltodextrin
Sponsors
Société des Produits Nestlé (SPN)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
4 Months to 30 Months
Healthy volunteers
Yes
Inclusion criteria
* Infants aged from 4-30 months (inclusive) at the time of enrolment (63 in each group). * With mild to severe atopic symptoms: SCORAD ≥ 20 (at V0b). * Having obtained his/her (or his/her legal representative's) written Informed Consent.
Exclusion criteria
* SCORAD inferior to 20 (SCORAD less than 20 at V0b). A SCORAD less than 20 at V0c is not an
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline SCORAD Score at 16 weeks of treatment | between 0 and 16 weeks of treatment | SCORAD documented during the longitudinal observational period of 16 weeks after the subject has enrolled |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Transepidermal water loss | 0, 4, 10 and 16 weeks | TEWL will be measured at V0, V1, V2 and V3 on 4 sites of both non-lesional and lesional appearing skin parts |
| Topical treatment used | during the 16 weeks of treatment | Topical treatment used (sparing effect) The corticoid sparing effect of the ingredient will be assessed in the placebo and the ingredient group. |
| total and specific IgE | 0 and 16 weeks | total and specific IgE |
| Quality of Life | 0, 4, 10, 16 weeks and 1 and 4 years later | The infants' dermatitis quality of life index (IDQOL) will be collected |
| assess the effect of the product on the safety parameters | 0 and 16 weeks | Biochemistry and Hematology parameters |
| 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 | — |
| Score A, B and C of the SCORAD | 0, 4, 10 and 16 weeks of treatment | 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) |
| Number and duration of atopic dermatitis episodes | during the 16 weeks intervention period | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Assessment of allergic history and skin disease | 1 and 4 years later | — |
| Cytokine quantification | 0 and 16 weeks of treatment | Cytokine quantification (multiplex) will be assessed in plasma of the patients |
| Genetic characterization of atopic dermatitis associated polymorphism | 0 week | Five major mutations in the FLG gene, one polymorphism in SPINK5 and one insertion in KLK7 gene will be analyzed in blood DNA |
| Diaper rash episodes and duration will be recorded by the parents/caregivers | duting the 16 weeks of treatment | Diaper rash episodes and duration will be recorded by the parents/caregivers |
| Perception/impression of the ingredient by the caregiver | at 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 |
Countries
Taiwan
Outcome results
None listed