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

Atopic Dermatitis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02103972
• Other study ID #: 11.46.NRC
• Status: Completed
• Phase: N/A
• First received: March 26, 2014
• Last updated: January 25, 2018
• Start date: July 2014
• Est. completion date: November 2017

Study information

• Verified date: January 2018
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: November 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Months to 30 Months

Eligibility

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.

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Dietary Supplement:
• GM080

• Maltodextrin

Locations

Country	Name	City	State
Taiwan	Linkou Chang Gung Memorial Hospital	Gueishan Township	Taoyuan County
Taiwan	Kaohsiung Municipal Hsiao-Kang Hospital	Kaohsiung City	Siaogang District
Taiwan	Kaohsiung Municipal TA-TUNG Hospital	Kaohsiung City	Qianjin District
Taiwan	Cardinal Tien Hospital	New Taipei City	Xindian District
Taiwan	Chung Shan Medical University Hospital	Taichung City	South District
Taiwan	Taipei Chang Gung Memorial Hospital of the Chang-Gung Medical foundation	Taipei City	Songshan District

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	Assessment of allergic history and skin disease		1 and 4 years later
Other	Cytokine quantification	Cytokine quantification (multiplex) will be assessed in plasma of the patients	0 and 16 weeks of treatment
Other	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	total and specific IgE	total and specific IgE	0 and 16 weeks
Secondary	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
Secondary	assess the effect of the product on the safety parameters	Biochemistry and Hematology parameters	0 and 16 weeks
Secondary	"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