Clinical trial NCT02103972: Assessment of Efficacy of the Consumption of a Heat-treated Lactobacillus Paracasei (GM080) on Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atopic Dermatitis
Keywords: All subjects of any ethnicity aged from 4 to 30 months with atopic dermatitis skin symptoms with a SCORAD equal or above 20
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2014-04-04
Enrollment: 126
Sex: ALL
Minimum age (years): 4
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change from Baseline SCORAD Score at 16 weeks of treatment
timeFrame: between 0 and 16 weeks of treatment
Secondary outcomes:
measure: Score A, B and C of the SCORAD
timeFrame: 0, 4, 10 and 16 weeks of treatment
measure: Number and duration of atopic dermatitis episodes
timeFrame: during the 16 weeks intervention period
measure: Transepidermal water loss
timeFrame: 0, 4, 10 and 16 weeks
measure: Topical treatment used
timeFrame: during the 16 weeks of treatment
measure: total and specific IgE
timeFrame: 0 and 16 weeks
measure: Quality of Life
timeFrame: 0, 4, 10, 16 weeks and 1 and 4 years later
measure: assess the effect of the product on the safety parameters
timeFrame: 0 and 16 weeks
measure: "Objective" SCORAD, which is composed of part A and B of the SCORAD (measured at V0, V1, V2 and V3)
timeFrame: 0, 4, 10 and 16 weeks
Other outcomes:
measure: Diaper rash episodes and duration will be recorded by the parents/caregivers
timeFrame: duting the 16 weeks of treatment
measure: Perception/impression of the ingredient by the caregiver
timeFrame: at 16 weeks
measure: Assessment of allergic history and skin disease
timeFrame: 1 and 4 years later
measure: Cytokine quantification
timeFrame: 0 and 16 weeks of treatment
measure: Genetic characterization of atopic dermatitis associated polymorphism
timeFrame: 0 week
Locations:
city: Kaohsiung City
country: Taiwan
facility: Kaohsiung Municipal TA-TUNG Hospital
state: Qianjin District
city: Kaohsiung City
country: Taiwan
facility: Kaohsiung Municipal Hsiao-Kang Hospital
state: Siaogang District
city: Taipei City
country: Taiwan
facility: Taipei Chang Gung Memorial Hospital of the Chang-Gung Medical foundation
state: Songshan District
city: Taichung City
country: Taiwan
facility: Chung Shan Medical University Hospital
state: South District
city: Gueishan Township
country: Taiwan
facility: Linkou Chang Gung Memorial Hospital
state: Taoyuan County
city: New Taipei City
country: Taiwan
facility: Cardinal Tien Hospital
state: Xindian District
Study officials:
References: