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Effect of synbiotic supplementation on children with atopic dermatitis: an observational prospective study.
Ibáñez, MD, Rodríguez Del Río, P, González-Segura Alsina, D, Villegas Iglesias, V
European journal of pediatrics. 2018;(12):1851-1858
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Abstract
The objective of this observational single-cohort prospective study was to assess the effect of synbiotic supplementation for 8 weeks in children with atopic dermatitis (AD). The synbiotic product contained Lactobacillus casei, Bifidobacterium lactis, Lactobacillus rhamnosus, Lactobacillus plantarum, fructooligosaccharide, galactooligosaccharide, and biotin. Patients were examined at baseline and at 8 weeks. Effectiveness of treatment was assessed with the Scoring Atopic Dermatitis (SCORAD) index. A total of 320 children (mean age 5.1 years, range 0-12 years) were included. The mean (SD) SCORAD index decreased from 45.5 (15.5) at baseline to 19.4 (14.6) at the end of treatment (P < 0.001), VAS score for pruritus decreased from 5.7 (2.2) to 2.3 (2.2) (P < 0.001), and VAS score for sleep decreased from 3.1 (2.5) to 1.1 (1.8) (P < 0.001). Percentage of children with moderate-severe disease decreased from 92.4% at baseline to 28.1% at week 8. In the multiple linear regression analysis, higher baseline SCORAD index (OR 0.51; 95% CI 0.41-0.61) and higher adherence (OR 7.29; 95% CI 1.85-12.73) were significantly associated with greater decrease in SCORAD index.Conclusion: Supplementation with the multistrain synbiotic product may improve AD in children. What is known: • Pediatric atopic dermatitis (AD) is a common, troublesome condition with limited treatment options, which has been shown to be associated with dysbiosis in the intestinal microflora. • Results of controlled clinical trials (RCTs) on the effect of probiotics in children with AD have been disparate, although overall, the data favor probiotics over placebo, with multistrain supplements associated with better improvements in AD. What is new: • The results of this observational, prospective, open-label, single-cohort study on 320 children with AD younger than 12 years old suggest that supplementation with multistrain synbiotics (Lactobacillus casei, Bifidobacterium lactis, Lactobacillus rhamnosus, Lactobacillus plantarum, fructooligosaccharide, galactooligosaccharide, and biotin) helps to improve AD symptoms in children. • More than 80% of children experienced improvement in AD symptoms, as measured by Severity Scoring of Atopic Dermatitis (SCORAD) index and assessed by parents and physicians. The main predictive factors for improvement was adherence to synbiotic treatment and high baseline SCORE index; the change in SCORAD did not depend on age, gender, presence of concomitant treatment, duration, and type of AD (persistent vs with flares), other concomitant allergies or history of parental allergy.
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KM110329 in adult patients with atopic dermatitis: a randomised, double-blind, placebo-controlled, multicentre trial--study protocol.
Cheon, C, Park, S, Park, JS, Oh, SM, Jang, S, Go, HY, Jang, BH, Shin, YC, Ko, SG
BMC complementary and alternative medicine. 2013;:335
Abstract
BACKGROUND Atopic dermatitis is a chronic inflammatory skin disease with a high prevalence rate and a large socioeconomic cost. There are many treatments for atopic dermatitis, such as antihistamine, tacrolimus and corticosteroids. However, due to concern about the adverse effects, many patients seek alternative treatments. In this context, natural products are gaining interest. KM110329 is a functional food consisting of four herbs that are beneficial to skin health. The purpose of this study is to assess the efficacy and safety of KM110329 for atopic dermatitis. METHODS/DESIGN This study is a randomised, double-blind, placebo-controlled and multicentre trial of KM110329. For this study, we will recruit 66 atopic dermatitis patients of both sexes, with ages ranging from 18 to 65, from three university hospitals. The participants will receive either KM110329 or a placebo twice a day for 8 weeks. The primary end point will be a change in the scoring atopic dermatitis (SCORAD) index. The secondary end points will include changes to the dermatology life quality index (DLQI) and transepidermal water loss (TEWL), among others. The outcomes will be measured at every visit. The study will be continued for 8 weeks and will include five visits with each subject (at screening and at 0, 1, 4 and 8 weeks). DISCUSSION This trial will provide research methodologies for evaluate clinical efficacy and safety of KM110329 in adult patients with atopic dermatitis. In addition, we will evaluate the changes in the general skin health status and quality of life. TRIAL REGISTRATIONS ClinicalTrials.gov NCT01692093.
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Polypodium leucotomos extract in atopic dermatitis: a randomized, double-blind, placebo-controlled, multicenter trial.
Ramírez-Bosca, A, Zapater, P, Betlloch, I, Albero, F, Martínez, A, Díaz-Alperi, J, Horga, JF, ,
Actas dermo-sifiliograficas. 2012;(7):599-607
Abstract
INTRODUCTION Topical corticosteroids are used to treat inflammation and relieve itching in atopic dermatitis, but their use is limited by adverse reactions. OBJECTIVES The main aim of this study was to investigate whether daily treatment with Polypodium leucotomos extract would reduce the use of topical corticosteroids in children and adolescents with atopic dermatitis. We also analyzed oral antihistamine use and changes in disease severity. PATIENTS AND METHODS We performed a phase IV randomized, double-blind, placebo-controlled, multicenter trial involving 105 patients aged between 2 and 17 years who were receiving topical corticosteroids to treat moderate atopic dermatitis. The patients were randomized to receive, in addition to their standard treatment, Polypodium leucotomos extract or placebo (both in capsule form) for 6 months. The percentage of days on which topical corticosteroids and other atopic dermatitis treatments were used was calculated. RESULTS Use of Polypodium leucotomos extract did not significantly reduce the mean (SD) percentage of days on which topical corticosteroids were used (11% [12%] vs 12% [11%] for placebo). A significant reduction was, however, observed for oral histamine use (median percentage of days, 4.5% in the Polypodium leucotomos group and 13.6% in the placebo group [P= .038]). The percentage of patients who used oral antihistamines was also lower in the Polypodium leucotomos group. CONCLUSION Long-term treatment with Polypodium leucotomos extract has benefits for children and adolescents with atopic dermatitis who require pharmacologic treatment to reduce inflammation and relieve itching.