Assessment of Efficacy of the Consumption of a Heat-treated Lactobacillus Paracasei (GM080) on Atopic Dermatitis

Study Overview
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Brief Summary
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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.

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Dietary Supplement: GM080
* Dietary Supplement: Maltodextrin


Participation Criteria
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Eligibility Criteria
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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 exclusion criteria. Infants who need a systemic treatment for their skin condition (e.g. glucocorticoids, steroids, cyclosporine A). Infants or mothers who introduce probiotics (other than the study product) in their diet during the 16-weeks intervention study. Of note: Infants or mothers who are used to consume a certain probiotic for more than 1 month before the start of the study (V0b), can continue to use this probiotic during the intervention period and will not be excluded. Recent introduction of probiotics, within a month before the planned start of the study (V0b) should be stopped and recorded; at least 1 month should be between stopping the consumption of the probiotic and V0b). Infants having other inflammatory skin diseases (urticaria, psoriasis). Infants having a congenital illness or malformation that may affect normal growth (especially immunodeficiency). Infants whose parents/caregivers cannot be expected to comply with the study procedures. Infants currently participating or having participated in another clinical study during the last 4 weeks prior to the beginning of this study. Infants using topical calcineurin inhibitors (e.g. tacrolimus and pimecrolimus (ELIDEL®)) during the study. Infants who have undergone in the month before the start of the study (V0b), are currently undergoing or are anticipated to undergo ultraviolet light therapy or wet dressing or any other topical treatment of their eczema other than the one provided in the study. Lotion and skin moisturizer are allowed but need to be monitored for frequency and area. The investigator and clinician will assess if the child has to be excluded based on the patient's medical condition and taken into account the values of the safety parameters tested. Therefore, no cut-off values, or normal ranges for the different safety parameters are exclusion criteria. It will be the responsibility of the investigator and clinician, based on their medical judgement, to decide if it is safe or not to include an infant into the study.

Ages Eligible for Study
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Minimum Age: 4 Months
Maximum Age: 30 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Maltodextrin<br>Maltodextrin | Dietary Supplement: Maltodextrin<br> <br> |
| Active Comparator: GM080<br>GM080 | Dietary Supplement: GM080<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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All subjects of any ethnicity aged from 4 to 30 months with atopic dermatitis skin symptoms with a SCORAD equal or above 20