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

Not Applicable

Completed

• Conditions: Atopic Dermatitis
• Interventions: Dietary Supplement: Maltodextrin; Dietary Supplement: GM080

• Registration Number: NCT02103972
• Lead Sponsor: Société des Produits Nestlé (SPN)

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-03-26
• Study First Submitted QC: 2014-04-03
• Study First Posted: 2014-04-04
• Study Start: 2014-07
• Primary Completion: 2017-07
• Study Completion: 2017-11
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-25
• Last Update Posted: 2018-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 126

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Maltodextrin	Maltodextrin	Maltodextrin
GM080	GM080	GM080

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)
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.
"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
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
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

Trial Locations

Locations (6)

Chung Shan Medical University Hospital; 🇨🇳 Taichung City, South District, Taiwan

Kaohsiung Municipal Hsiao-Kang Hospital; 🇨🇳 Kaohsiung City, Siaogang District, Taiwan

Taipei Chang Gung Memorial Hospital of the Chang-Gung Medical foundation; 🇨🇳 Taipei City, Songshan District, Taiwan

Linkou Chang Gung Memorial Hospital; 🇨🇳 Gueishan Township, Taoyuan County, Taiwan

Kaohsiung Municipal TA-TUNG Hospital; 🇨🇳 Kaohsiung City, Qianjin District, Taiwan

Cardinal Tien Hospital; 🇨🇳 New Taipei City, Xindian District, Taiwan