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

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.

Study Overview

• Status: Completed
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Dietary supplement: Maltodextrin; Dietary supplement: GM080

• Study Type: Interventional
• Enrollment (Actual): 126
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Qianjin District
    • Kaohsiung City, Qianjin District, Taiwan, 801
      • Kaohsiung Municipal Ta-Tung Hospital
  • Siaogang District
    • Kaohsiung City, Siaogang District, Taiwan, 812
      • Kaohsiung Municipal Hsiao-Kang Hospital
  • Songshan District
    • Taipei City, Songshan District, Taiwan, 105
      • Taipei Chang Gung Memorial Hospital of the Chang-Gung Medical foundation
  • South District
    • Taichung City, South District, Taiwan, 402
      • Chung Shan Medical University Hospital
  • Taoyuan County
    • Gueishan Township, Taoyuan County, Taiwan, 333
      • Linkou Chang Gung Memorial Hospital
  • Xindian District
    • New Taipei City, Xindian District, Taiwan, 231
      • Cardinal Tien Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 months to 2 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Maltodextrin	Dietary supplement: Maltodextrin
ACTIVE_COMPARATOR: GM080	Dietary supplement: GM080

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diaper rash episodes and duration will be recorded by the parents/caregivers	Diaper rash episodes and duration will be recorded by the parents/caregivers	duting the 16 weeks of treatment
Perception/impression of the ingredient by the caregiver	At the end of the 16 weeks intervention trial, the perception of the caregivers toward the ingredient they were randomized to, will be assessed	at 16 weeks
Assessment of allergic history and skin disease		1 and 4 years later
Cytokine quantification	Cytokine quantification (multiplex) will be assessed in plasma of the patients	0 and 16 weeks of treatment
Genetic characterization of atopic dermatitis associated polymorphism	Five major mutations in the FLG gene, one polymorphism in SPINK5 and one insertion in KLK7 gene will be analyzed in blood DNA	0 week

Collaborators and Investigators

• Sponsor: Nestlé

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (ACTUAL): July 1, 2017
• Study Completion (ACTUAL): November 1, 2017

Study Registration Dates

• First Submitted: March 26, 2014
• First Submitted That Met QC Criteria: April 3, 2014
• First Posted (ESTIMATE): April 4, 2014

Study Record Updates

• Last Update Posted (ACTUAL): January 26, 2018
• Last Update Submitted That Met QC Criteria: January 25, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: All subjects of any ethnicity aged from 4 to 30 months with atopic dermatitis skin symptoms with a SCORAD equal or above 20
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic
• Other Study ID Numbers: 11.46.NRC