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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2017-11-30

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.

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Detailed Description

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Conditions

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Atopic Dermatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Maltodextrin

Group Type PLACEBO_COMPARATOR

Maltodextrin

Intervention Type DIETARY_SUPPLEMENT

GM080

Group Type ACTIVE_COMPARATOR

GM080

Intervention Type DIETARY_SUPPLEMENT

Interventions

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GM080

Intervention Type DIETARY_SUPPLEMENT

Maltodextrin

Intervention Type DIETARY_SUPPLEMENT

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

* 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.

Minimum Eligible Age

4 Months

Maximum Eligible Age

30 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes