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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.
J Microbiol Immunol Infect. 2017 Oct; 50(5):684-692.JM

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+Show Affiliations

Department of Pediatrics, Chung-Shan Medical University Hospital, Taichung City, Taiwan, ROC.Taipei City Hospital, Ren-Ai Branch, Taipei City, Taiwan, ROC; Siyuan Hospital, Taipei City, Taiwan, ROC.Taipei City Hospital, Ren-Ai Branch, Taipei City, Taiwan, ROC.Department of Pediatrics, Chung-Shan Medical University Hospital, Taichung City, Taiwan, ROC; School of Medicine, Chung Shan Medical University, Taichung City, Taiwan, ROC.Department of Pediatrics, Chung-Shan Medical University Hospital, Taichung City, Taiwan, ROC.Department of Pediatrics, Chung-Shan Medical University Hospital, Taichung City, Taiwan, ROC; School of Medicine, Chung Shan Medical University, Taichung City, Taiwan, ROC.School of Medicine, Chung Shan Medical University, Taichung City, Taiwan, ROC.Department of Pediatrics, Chung-Shan Medical University Hospital, Taichung City, Taiwan, ROC; School of Medicine, Chung Shan Medical University, Taichung City, Taiwan, ROC.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.

Pub Type(s)

Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

26733351

Citation

Wu, Yi-Jie, et al. "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." Journal of Microbiology, Immunology, and Infection = Wei Mian Yu Gan Ran Za Zhi, vol. 50, no. 5, 2017, pp. 684-692.
Wu YJ, Wu WF, Hung CW, et al. 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. J Microbiol Immunol Infect. 2017;50(5):684-692.
Wu, Y. J., Wu, W. F., Hung, C. W., Ku, M. S., Liao, P. F., Sun, H. L., Lu, K. H., Sheu, J. N., & Lue, K. H. (2017). 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. Journal of Microbiology, Immunology, and Infection = Wei Mian Yu Gan Ran Za Zhi, 50(5), 684-692. https://doi.org/10.1016/j.jmii.2015.10.003
Wu YJ, et al. 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. J Microbiol Immunol Infect. 2017;50(5):684-692. PubMed PMID: 26733351.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Wu,Yi-Jie, AU - Wu,Wei-Fong, AU - Hung,Chia-Wei, AU - Ku,Ming-Shiu, AU - Liao,Pei-Fen, AU - Sun,Hai-Lun, AU - Lu,Ko-Hsiu, AU - Sheu,Ji-Nan, AU - Lue,Ko-Huang, Y1 - 2015/11/27/ PY - 2014/12/27/received PY - 2015/08/25/revised PY - 2015/10/08/accepted PY - 2016/1/7/pubmed PY - 2018/6/14/medline PY - 2016/1/7/entrez KW - Lactobacillus rhamnosus KW - atopic dermatitis KW - efficacy SP - 684 EP - 692 JF - Journal of microbiology, immunology, and infection = Wei mian yu gan ran za zhi JO - J Microbiol Immunol Infect VL - 50 IS - 5 N2 - 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. SN - 1995-9133 UR - https://www.unboundmedicine.com/medline/citation/26733351/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_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1684-1182(15)00898-1 DB - PRIME DP - Unbound Medicine ER -