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

NCT02103972 | Completed

• 1 other identifier: 11.46.NRC
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 6

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Score A, B and C of the SCORAD

  0, 4, 10 and 16 weeks of treatment

• Number and duration of atopic dermatitis episodes

  during the 16 weeks intervention period

• Transepidermal water loss

  0, 4, 10 and 16 weeks

• Topical treatment used

  during the 16 weeks of treatment

• total and specific IgE

  0 and 16 weeks

Other Outcomes (5)

• 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 16 weeks

• Assessment of allergic history and skin disease

  1 and 4 years later

Study Arms (2)

Maltodextrin

PLACEBO COMPARATOR

Maltodextrin

Dietary Supplement: Maltodextrin

GM080

ACTIVE COMPARATOR

GM080

Dietary Supplement: GM080

Interventions

GM080 DIETARY_SUPPLEMENT

GM080

Maltodextrin DIETARY_SUPPLEMENT

Maltodextrin

Eligibility Criteria

• Age: 4 Months - 30 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead

Study Sites (6)

Kaohsiung Municipal TA-TUNG Hospital

Kaohsiung City, Qianjin District, 801, Taiwan

Location

Kaohsiung Municipal Hsiao-Kang Hospital

Kaohsiung City, Siaogang District, 812, Taiwan

Location

Taipei Chang Gung Memorial Hospital of the Chang-Gung Medical foundation

Taipei, Songshan District, 105, Taiwan

Location

Chung Shan Medical University Hospital

Taichung, South District, 402, Taiwan

Location

Linkou Chang Gung Memorial Hospital

Gueishan Township, Taoyuan County, 333, Taiwan

Location

Cardinal Tien Hospital

New Taipei City, Xindian District, 231, Taiwan

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

maltodextrin

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2014
• First Posted: April 4, 2014
• Study Start: July 1, 2014
• Primary Completion: July 1, 2017
• Study Completion: November 1, 2017
• Last Updated: January 26, 2018

Record last verified: 2018-01

Locations

TW (6)