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A Randomized, Double-Blind, Placebo-Controlled Trial Assessing the Oral Administration of a Heat-Treated
Dah-Chin Yan1, Chih-Hsing Hung2, Leticia B Sy3
1Taipei Chang Gung Memorial Hospital, Taipei, Taiwan.
Insights
Heat-treated Lactobacillus paracasei GM-080 did not improve atopic dermatitis (AD) in infants when used alongside topical corticosteroids. The probiotic did not offer a significant benefit over placebo in reducing AD severity or corticosteroid use.
Area of Science:
- Pediatric Dermatology
- Microbiology
- Immunology
Background:
- Atopic dermatitis (AD) is a prevalent infant condition often managed with topical steroids, which carry potential side effects.
- There is a need for innovative therapies to alleviate AD burden and reduce infant corticosteroid dependency.
Purpose of the Study:
- To evaluate the efficacy of heat-treated Lactobacillus paracasei GM-080 as a supplementary treatment for infant atopic dermatitis.
- To assess the probiotic's impact on clinical outcomes and its potential corticosteroid-sparing effect.
Main Methods:
- A 16-week randomized controlled trial involving infants (4-30 months) with AD.
- Participants received daily heat-treated Lactobacillus paracasei GM-080 or placebo, alongside fluticasone propionate cream.
- Outcomes included SCORAD, Transepidermal Water Loss (TEWL), Infants' Dermatitis Quality of Life Index (IDQOL), and IgE levels.
Main Results:
- Both groups showed significant reductions in SCORAD, objective SCORAD, itching, and IDQOL.
- No significant differences were observed between the probiotic and placebo groups for most outcomes.
- Total IgE levels increased in both groups, with a significantly higher increase in the probiotic group.
Conclusions:
- Heat-treated Lactobacillus paracasei GM-080 did not demonstrate benefit as an adjunct therapy for infant atopic dermatitis.
- The study found no evidence of a corticosteroid-sparing effect with the probiotic intervention.
- Potential mild benefits of the probiotic might have been obscured by the use of a moderate-potency corticosteroid.
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.
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