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

Nestlé

Status

Completed

Conditions

Atopic Dermatitis

Treatments

Dietary Supplement: GM080

Dietary Supplement: Maltodextrin

Study type

Interventional

Funder types

Industry

Identifiers

NCT02103972

11.46.NRC

Details and patient eligibility

About

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.

Enrollment

126 patients

Sex

All

Ages

4 to 30 months old

Volunteers

Accepts Healthy Volunteers

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.