Prevention of atopic dermatitis in high-risk neonates via different types of moisturizer application: A randomized, blinded, parallel, three-group, phase II trial (PAF study).

BACKGROUND: The effectiveness of moisturizers in preventing infant atopic dermatitis (AD) remains unclear. We previously showed that using 2e moisturizer of commercial moisturizer (Shiseido Japan Co., Ltd.) at least once a day significantly prevented AD in infants as compared with as-needed petroleum jelly. This trial aimed to determine the effectiveness of twice- or once-daily application of Fam's Baby moisturizer (Fam's Inc.) in preventing AD compared with once-daily 2e moisturizer. METHODS: This trial was a single-centre, three-parallel-group, assessor-blinded, superiority, individually randomized, controlled, phase II trial that was conducted from 25 August 2020 to 28 September 2021. We randomly assigned 60 newborns with at least one parent or sibling who has AD to receive Fam's Baby moisturizer twice daily (Group A) or once daily (Group B), or 2e once daily (Group C) in a 1:1:1 ratio until they were 32 weeks old. The primary outcome was the time of AD onset. RESULTS: Atopic dermatitis was observed in 11/20 (55%), 5/20 (25%) and 10/20 (50%), infants in Groups A, B and C, respectively. Cumulative incidence values for AD according to the Kaplan-Meier method showed that infants in Group B tended to maintain an intact skin for a longer period than those in Group C (median time, not reached [NR] vs. 212 days, log-rank test, p = 0.064). Cox regression analysis showed that the risk of AD tended to be lower in Group B (hazard ratio with group C as control, 0.36; 95% confidential intervals: 0.12-1.06). No serious adverse events occurred in any of the enrolled infants. CONCLUSION: Fam's Baby moisturizer may better prevent AD than 2e. Further large-scale trials should be performed to confirm the efficacy of Fam's Baby moisturizer in preventing AD in infants.

Combination of heat-killed Lactiplantibacillus plantarum YIT 0132 (LP0132) and oral immunotherapy in cow's milk allergy: a randomised controlled trial.

Safer and more effective cow milk (CM)-oral immunotherapy that does not induce allergic reactions has not yet been standardised. We sought to explore the efficacy and feasibility of a combination of heat-killed Lactiplantibacillus plantarum YIT 0132 (LP0132) and oral immunotherapy for treating IgE-mediated cow milk allergy (CMA). We conducted a 24-week, double-blind, randomised (1:1), two-arm, parallel-group, placebo-controlled, phase 2 trial of LP0132 intervention for treating IgE-mediated CMA in children aged 1-18 years (n=60) from January 29, 2018 to July 12, 2019 in Tokyo, Japan. Participants were randomly assigned to the LP0132 group receiving citrus juice fermented with LP0132 or to the control group receiving citrus juice without. Both groups received low-dose slow oral immunotherapy with CM. The primary outcome was improved tolerance to CM, proven by the CM challenge test at 24 weeks. Secondary outcomes were changes in serum biomarkers of serum-specific ß-lactoglobulin-IgE (sIgE) and ß-lactoglobulin-IgG4 (sIgG4). Exploratory outcomes included changes in serum cytokine levels and gut microbiota composition. A total of 61 participants were included. Finally, 31 children were assigned to the LP0132 group and 30 to the control group, respectively. After the intervention, 41.4 and 37.9% of the participants in the LP0132 and control groups, respectively, showed improved tolerance to CM. In serum biomarkers after the intervention, the sIgG4 level was significantly higher, and interleukin (IL)-5 and IL-9 were significantly lower, in the LP0132 group than in the control group. In the gut microbiome, the α-diversity and Lachnospiraceae increased significantly in the LP0132 group, and Lachnospiraceae after the intervention was significantly higher in the LP0132 group than in the control group. In conclusion, low-dose oral immunotherapy with modulating gut microbiota might be a safer and more effective approach for treating cow's milk allergy.