Dah-Chin Yan1, Chih-Hsing Hung2, Leticia B Sy3, Ko-Huang Lue4, I-Hsin Shih5, Chin-Yi Yang5, Li-Chen Chen5, Hai-Lun Sun4, Min-Sheng Lee6, Julie Chambard7, Jérôme Tanguy7, Betsy Hughes-Formella8, Sophie Nutten7, Carine Blanchard9. 1. Taipei Chang Gung Memorial Hospital, Taipei, Taiwan. 2. Kaohsiung Municipal Hsiao Kang Hospital, Kaohsiung City, Taiwan. 3. Cardinal Tien Hospital, New Taipei City, Taiwan. 4. Chung Shan Medical University Hospital, Taichung City, Taiwan. 5. Linkou Chang Gung Memorial Hospital, Taoyuan City, Taiwan. 6. Kaohsiung Municipal Ta-Tung Hospital, Kaohsiung City, Taiwan. 7. Nestlé Research, Lausanne, Switzerland. 8. Independent Consultant, Reinbek, Germany. 9. Nestlé Research, Lausanne, Switzerland, carine.blanchard@rdyo.nestle.com.
Abstract
BACKGROUND/AIMS: Atopic dermatitis (AD) is a common disease in infancy, for which topical steroids are the first-line therapy but have side effects. Innovative approaches are needed to reduce the burden of AD and corticosteroid usage in infants. METHODS: The once-daily consumption of heat-treated probiotic Lactobacillus paracasei GM-080 or placebo for 16 weeks as supplementary approach to topical treatment with fluticasone propionate cream was compared in AD infants aged 4-30 months. Outcomes were SCORAD and its subscores, TEWL, Infants' Dermatitis Quality of Life Index (IDQOL), corticoid "sparing effect," CCL17/TARC, and IgE status. RESULTS:SCORAD, objective SCORAD, itching, and IDQOL decreased significantly (p < 0.001) over the treatment period in both treatment groups. Slight decreases (ns) were noted in TEWL in lesional and unaffected skin and CCL17 levels. There were no differences between the treatment groups. Total IgE increased over the treatment period in both groups, with significantly higher increase in the heat-treated probiotic group (p = 0.038). There was no evidence of a corticoid "sparing effect" by the probiotic. CONCLUSIONS: In this design, the probiotic L. paracasei was not beneficial as a complementary approach to topical corticosteroids in infants with AD. However, slight beneficial effects may have been masked by the moderate potency corticoid.
RCT Entities:
BACKGROUND/AIMS: Atopic dermatitis (AD) is a common disease in infancy, for which topical steroids are the first-line therapy but have side effects. Innovative approaches are needed to reduce the burden of AD and corticosteroid usage in infants. METHODS: The once-daily consumption of heat-treated probiotic Lactobacillus paracaseiGM-080 or placebo for 16 weeks as supplementary approach to topical treatment with fluticasone propionate cream was compared in ADinfants aged 4-30 months. Outcomes were SCORAD and its subscores, TEWL, Infants' Dermatitis Quality of Life Index (IDQOL), corticoid "sparing effect," CCL17/TARC, and IgE status. RESULTS: SCORAD, objective SCORAD, itching, and IDQOL decreased significantly (p < 0.001) over the treatment period in both treatment groups. Slight decreases (ns) were noted in TEWL in lesional and unaffected skin and CCL17 levels. There were no differences between the treatment groups. Total IgE increased over the treatment period in both groups, with significantly higher increase in the heat-treated probiotic group (p = 0.038). There was no evidence of a corticoid "sparing effect" by the probiotic. CONCLUSIONS: In this design, the probiotic L. paracasei was not beneficial as a complementary approach to topical corticosteroids in infants with AD. However, slight beneficial effects may have been masked by the moderate potency corticoid.