title: Evaluation of efficacy and safety of Lactobacillus rhamnosus in children aged 4-48 months with atopic dermatitis: An 8-week, double-blind, randomized, placebo-controlled study.
abstract: OBJECTIVE
  The main objective of this study was to evaluate the efficacy and safety of Lactobacillus rhamnosus in children aged 4-48 months with atopic dermatitis.
  
  
  METHODS
  The design of this study was a two-center, double-blind, randomized, and placebo-controlled study with two parallel groups to evaluate the efficacy and safety profile of L. rhamnosus in children aged 4-48 months with atopic dermatitis diagnosed using Hanifin and Rajka criteria and with a Scoring of Atopic Dermatitis (SCORAD) ≥ 15 at enrollment. The duration of this study was 8 weeks with a total of five visits. The enrolled patients were allocated into either a treatment group (one ComProbi capsule containing L. rhamnosus a day) or a control group (one capsule of placebo a day) at a ratio of 1:1. The primary endpoint was to compare the mean change from baseline in SCORAD after 8 weeks of treatment. The other secondary end points were to compare the following: the mean changes from baseline in SCORAD at postbaseline visits, the frequency and total amount of the use of corticosteroids during the 8-week treatment, the frequency of atopic dermatitis and the symptom-free duration, the mean changes from baseline in Infant Dermatitis Quality of Life Questionnaire at Week 4 and Week 8, and the mean changes from baseline in the Dermatitis Family Impact Questionnaire at Week 4 and Week 8.
  
  
  RESULTS
  The mean changes in SCORAD from baseline at Week 8 was -21.69 ± 16.56 in the L. rhamnosus group and -12.35 ± 12.82 in the placebo group for the intent-to-treat population (p = 0.014). For the per-protocol population, the mean change of SCORAD from baseline was -23.20 ± 15.24 in the L. rhamnosus group and -12.35 ± 12.82 in the placebo group (p = 0.003). Significant differences were demonstrated between groups at Week 8 in intensity in the intent-to-treat population and per-protocol population. Throughout the period, the amount of topical corticosteroids used showed no difference between groups. No significant difference was noted in the overall symptom-free durations compared with the placebo group. Infant Dermatitis Quality of Life Questionnaires and Dermatitis Family Impact Questionnaires scores improved significantly at Week 4 and Week 8 but did not reach statistical significance. Adverse events were documented in 14/33 patients in the L. rhamnosus group (42.42%, 35 events) and in 15/33 placebo patients (45.45%, 37 events).
  
  
  CONCLUSIONS
  The results of this study indicated that L. rhamnosus was effective in decreasing symptoms of atopic dermatitis after an 8-week treatment by comparing the mean change of SCORAD from baseline with a placebo (p < 0.05). The reduction in SCORAD resulted from a consistent decrease in all components of SCORAD. Patients who took L. rhamnosus for 8 weeks expressed less SCORAD in the three components: area of affected skin, intensity of atopic dermatitis, and patient symptoms, with a significant decrease in the mean change of intensity from baseline compared with placebo.
authors.affiliation: Department of Pediatrics, Chung-Shan Medical University Hospital, Taichung City, Taiwan, ROC.
authors.forename: Yi-Jie
authors.initials: YJ
authors.lastname: Wu
authors.affiliation: Taipei City Hospital, Ren-Ai Branch, Taipei City, Taiwan, ROC; Siyuan Hospital, Taipei City, Taiwan, ROC.
authors.forename: Wei-Fong
authors.initials: WF
authors.lastname: Wu
authors.affiliation: Taipei City Hospital, Ren-Ai Branch, Taipei City, Taiwan, ROC.
authors.forename: Chia-Wei
authors.initials: CW
authors.lastname: Hung
authors.affiliation: Department of Pediatrics, Chung-Shan Medical University Hospital, Taichung City, Taiwan, ROC; School of Medicine, Chung Shan Medical University, Taichung City, Taiwan, ROC.
authors.forename: Ming-Shiu
authors.initials: MS
authors.lastname: Ku
authors.affiliation: Department of Pediatrics, Chung-Shan Medical University Hospital, Taichung City, Taiwan, ROC.
authors.forename: Pei-Fen
authors.initials: PF
authors.lastname: Liao
authors.affiliation: Department of Pediatrics, Chung-Shan Medical University Hospital, Taichung City, Taiwan, ROC; School of Medicine, Chung Shan Medical University, Taichung City, Taiwan, ROC.
authors.forename: Hai-Lun
authors.initials: HL
authors.lastname: Sun
authors.affiliation: School of Medicine, Chung Shan Medical University, Taichung City, Taiwan, ROC.
authors.forename: Ko-Hsiu
authors.initials: KH
authors.lastname: Lu
authors.affiliation: Department of Pediatrics, Chung-Shan Medical University Hospital, Taichung City, Taiwan, ROC; School of Medicine, Chung Shan Medical University, Taichung City, Taiwan, ROC.
authors.forename: Ji-Nan
authors.initials: JN
authors.lastname: Sheu
authors.affiliation: Department of Pediatrics, Chung-Shan Medical University Hospital, Taichung City, Taiwan, ROC; School of Medicine, Chung Shan Medical University, Taichung City, Taiwan, ROC; Institute of Medicine, Chung Shan Medical University, Taichung, Taiwan, ROC. Electronic address: cshy095@csh.org.tw.
authors.forename: Ko-Huang
authors.initials: KH
authors.lastname: Lue
mesh_terms: D000305:Adrenal Cortex Hormones / Q000627:therapeutic use; D002675:Child, Preschool; D003876:Dermatitis, Atopic / Q000628:therapy*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007223:Infant; D052201:Lacticaseibacillus rhamnosus / Q000502:physiology*; D008297:Male; D010290:Parents; D010919:Placebos; D019936:Probiotics / Q000627:therapeutic use*; D011788:Quality of Life; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires; D013624:Taiwan; D016896:Treatment Outcome
chemical_list: D000305:Adrenal Cortex Hormones; D010919:Placebos
keywords: Lactobacillus rhamnosus; atopic dermatitis; efficacy